Code of Federal Regulations · Section
§ 870.1120 — Blood Pressure Cuff
21 C.F.R. § 870.1120
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(a) Identification. A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.
(b) Classification. Class II (performance standards).
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351