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510(k) Data Aggregation

    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
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SANAPHON N

    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.

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