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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
    Why did this record match?
    Applicant Name (Manufacturer) :

    Origin Medical Devices

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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) <1500 gm to adult and for a wide variety of clinical conditions. The device is intended to be used in hospital type facilities and during hospital and hospital-type transport provided that electrical power and compressed Oxygen are supplied.
    Device Description
    Not Found
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