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510(k) Data Aggregation

    K Number
    K213098
    Device Name
    Panther 5
    Manufacturer
    Origin Medical Devices
    Date Cleared
    2023-07-20

    (664 days)

    Product Code
    CBK
    Regulation Number
    868.5895
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Panther 5 is intended to provide continuous ventilation to patients requiring respiratory support. The device is intended for patients from neonates with Veight (VLBW)

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a medical device called "Panther 5" (Regulation Name: Continuous Ventilator). It discusses the regulatory process and general compliance requirements.

    However, the document DOES NOT contain the specific information requested regarding acceptance criteria, device performance, study details (sample size, data provenance, expert qualifications, adjudication methods), MRMC studies, standalone performance, types of ground truth, or training set details.

    Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the detailed questions about the study that proves the device meets the acceptance criteria from the given text.

    The provided document is purely a regulatory clearance letter, not a clinical study report or a summary of performance data.

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