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510(k) Data Aggregation

    K Number
    K972899
    Device Name
    CYPRESS MEDICAL PRODUCTS ANEROID SPHYGMOMANOMETER
    Manufacturer
    CYPRESS MEDICAL PRODUCTS, LTD.
    Date Cleared
    1998-07-07

    (335 days)

    Product Code
    DXQ
    Regulation Number
    870.1120
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CYPRESS MEDICAL PRODUCTS ANEROID SPHYGMOMANOMETER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    An Aneroid Sphygmomanometer is a non-invasive medical device intended to measure the systolic and diastolic blood pressures by means of a manually inflatable cuff and a manometer analog gauge.

    Device Description

    An Aneroid Sphygmomanometer is a non-invasive medical device intended to measure the systolic and diastolic blood pressures by means of a manually inflatable cuff and a manometer analog gauge.

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for an Aneroid Sphygmomanometer. It declares the device substantially equivalent to a legally marketed predicate device. However, this document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

    The letter only states that the device is "substantially equivalent" to a predicate device and can therefore be marketed. To provide the requested information, a different type of document (e.g., a summary of safety and effectiveness, or a full study report) would be needed.

    Therefore, I cannot fulfill your request based on the provided input.

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