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K Number
K964648
Device Name
PROTECT ALL BLOOD PRESSURE CUFF COVER
Manufacturer
PROTECT ALL, INC.
Date Cleared
1997-02-18

(90 days)

Product Code
DXQ
Regulation Number
870.1120
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 870.1120 Blood pressure cuff.

(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).