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21 C.F.R. § 870.1025   Arrhythmia detector and alarm (including ST-segment measurement and alarm).

Title 21 - Food and Drugs

Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart B—Cardiovascular Diagnostic Devices

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§ 870.1025   Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a) Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.

(b) Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See §870.1 for the availability of this guidance document.

[68 FR 61344, Oct. 28, 2003]

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