21 C.F.R. § 868.5115 Device to relieve acute upper airway obstruction.
Title 21 - Food and Drugs
(a) Identification. The device is a raised, rounded pad that, in the event of choking on a foreign body, can be applied to the abdomen and pushed upward to generate expulsion pressure to remove the obstruction to relieve acute upper airway obstruction. (b) Classification. Class II (special controls) (“Class II Special Control Guidance Document for Acute Upper Airway Obstruction Devices”). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to §868.9. [65 FR 39099, June 23, 2000; 65 FR 47669, Aug. 3, 2000]
Title 21: Food and Drugs
PART 868—ANESTHESIOLOGY DEVICES
Subpart F—Therapeutic Devices
§ 868.5115 Device to relieve acute upper airway obstruction.
