21 C.F.R. PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES
TITLE 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES
Subpart A--GENERAL PROVISIONS
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Effective dates of requirement for premarket approval.
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Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
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Subpart B--[RESERVED]
Subpart C--GENERAL HOSPITAL AND PERSONAL USE MONITORING DEVICES
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Liquid crystal forehead temperature strip.
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Electronic monitor for gravity flow infusion systems.
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Electrically powered spinal fluid pressure monitor.
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Sterilization process indicator.
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Clinical color change thermometer.
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Clinical electronic thermometer.
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Clinical mercury thermometer.
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Subparts D-E--[RESERVED]
Subpart F--GENERAL HOSPITAL AND PERSONAL USE THERAPEUTIC DEVICES
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Medical recirculating air cleaner.
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AC-powered adjustable hospital bed.
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Hydraulic adjustable hospital bed.
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Manual adjustable hospital bed.
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Nonpowered flotation therapy mattress.
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Therapeutic medical binder.
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Intravascular catheter securement device.
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Medical adhesive tape and adhesive bandage.
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Neonatal transport incubator.
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Pressure infusor for an I.V. bag.
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Nonelectrically powered fluid injector.
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Intravascular administration set.
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Patient care reverse isolation chamber.
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Non-AC-powered patient lift.
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Alternating pressure air flotation mattress.
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Temperature regulated water mattress.
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Hypodermic single lumen needle.
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Pediatric position holder.
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Neonatal phototherapy unit.
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Chemical cold pack snakebite kit.
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Medical support stocking.
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Therapeutic scrotal support.
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Umbilical occlusion device.
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Subcutaneous, implanted, intravascular infusion port and catheter.
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Percutaneous, implanted, long-term intravascular catheter.
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Subpart G--GENERAL HOSPITAL AND PERSONAL USE MISCELLANEOUS DEVICES
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Absorbent tipped applicator.
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Medical disposable bedding.
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Cardiopulmonary resuscitation board.
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Ethylene oxide gas aerator cabinet.
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Ultrasonic cleaner for medical instruments.
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Mattress cover for medical purposes.
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Patient examination glove.
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Implantable radiofrequency transponder system for patient identification and health information.
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AC-powered medical examination light.
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Battery-powered medical examination light.
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Liquid medication dispenser.
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Skin pressure protectors.
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Medical ultraviolet air purifier.
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Medical ultraviolet water purifier.
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Vacuum-powered body fluid suction apparatus.
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Powered patient transfer device.
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Manual patient transfer device.
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Washers for body waste receptacles.
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Medical disposable scissors.
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Ethylene oxide gas sterilizer.
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Liquid chemical sterilants/high level disinfectants.
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General purpose disinfectants.
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Syringe needle introducer.
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Liquid crystal vein locator.
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Medical washer-disinfector.
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