K Number
K003415Device Name
ANEROID SPHYGMOMANOMETER WITH STETHOSCOPEManufacturer
Date Cleared
2001-01-03
(62 days)
Product Code
Regulation Number
870.1120Type
TraditionalPanel
CardiovascularReference & Predicate Devices
N/A
Predicate For
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).