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510(k) Data Aggregation

    K Number
    K970158
    Device Name
    BABYPAC
    Manufacturer
    PNEUPAC, INC.
    Date Cleared
    1998-04-28

    (467 days)

    Product Code
    CBK,MNT
    Regulation Number
    868.5895
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    PNEUPAC, INC.

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

    The babyPAC pneumatically powered ventilator is specifically designed for use by qualified medical caregivers, paramedics and other trained personnel for patient ventilation during respiratory distress or insufficiency in the rescue, pre-hospital and alternative site arenas.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "babyPAC." It confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed.

    This document does not contain the information necessary to describe:

    • Acceptance criteria and reported device performance.
    • Details about a study proving the device meets acceptance criteria (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods).
    • Information on MRMC comparative effectiveness studies or standalone algorithm performance.
    • Training set details.

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

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