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510(k) Data Aggregation

    K Number
    K080189
    Device Name
    TEMPA-KUFF SOFT BLOOD PRESSURE CUFF, MODEL 39XXX ; VINYL,MODEL 99XXX
    Manufacturer
    TRIMLINE MEDICAL PRODUCTS CORP.
    Date Cleared
    2008-08-15

    (203 days)

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

    The TRIMLINE Tempa-Kuff Blood Pressure Cuff:

    • is an accessory used in conjunction with non-invasive blood pressure measuring systems
    • is non-sterile and may be used on a limited basis :
    • . may be used with neonatal, pediatric and adult patients
    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter from the FDA for the TRIMLINE™ Tempa-Kuff® Blood Pressure Cuff. It confirms that the device is substantially equivalent to legally marketed predicate devices.

    The provided text does not contain any information about acceptance criteria, performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment. Therefore, I cannot fulfill your request based on the given input.

    The document is purely a regulatory approval letter and does not describe the technical details of the device's validation.

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