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510(k) Data Aggregation

    K Number
    K971892
    Device Name
    BIOMEDICAL HORIZONS INC. COMPRESSION PUMP, MODEL 651
    Manufacturer
    BIOMEDICAL HORIZONS, INC.
    Date Cleared
    1998-08-05

    (440 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Common Indications
    Peripheral edema
    Lymphedema (Postmastectomy, congenital)
    Venous Stasis Ulcers
    Stump reduction
    Hand edema

    Device Description

    Compression Pump, Model 651

    AI/ML Overview

    I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) clearance letter from the FDA for a compression pump and does not contain information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a device's performance. It primarily focuses on the substantial equivalence determination for marketing the device.

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