C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER H—MEDICAL DEVICES › PART 870—CARDIOVASCULAR DEVICES › Subpart B—Cardiovascular Diagnostic Devices

21 C.F.R. § 870.1025

Arrhythmia detector and alarm (including ST-segment measurement and alarm)

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(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]
Notes of Decisions
Cited in 1 case, 1995–1995 · leading case: Michael v. Shiley, Inc. (3rd Cir. 1995).
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Michael v. Shiley, Inc. (3rd Cir. 1995). “170 (regulating the testing and manufacture of intraocular lenses); 21 C.F.R. § 870.1025 - 870.5925 (classifying and imposing requirements on various cardiovascular devices).”
Annotations are extracted automatically from the opinions in the Syfert caselaw corpus and ranked by authority, recency, and treatment. Dots show Syfertize treatment of the citing case itself.