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K Number
K972378
Device Name
SANAPHON N
Manufacturer
RUDOLF RIESTER GMBH & CO. KG
Date Cleared
1997-09-24

(90 days)

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

Sanaphon-N is a sphygmomanometer and is intended to measure the blood pressure (self-meaurement)

Device Description

Sanaphon-N is a sphygmomanometer

AI/ML Overview

The provided text does not contain information on acceptance criteria, device performance, or any studies proving the device meets acceptance criteria. The document is a 510(k) clearance letter from the FDA for a device named SanaPhon-N, indicating its substantial equivalence to a predicate device. It defines the intended use as a sphygmomanometer for self-measurement of blood pressure.

Therefore, I cannot provide the requested information about acceptance criteria or study details from this document.

§ 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).