BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇹🇼 Taiwan

    POCKET RESCUE

    K Number: K970688 · Decision Sep 26, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    12
    Applicant Total
    6
    Review Days
    213

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    Basic Information

    Device Name
    POCKET RESCUE
    K Number
    K970688
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5570
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cheen Houng Ent. Co. , Ltd.
    Date Received
    February 25, 1997
    Decision Date
    September 26, 1997
    Product Code
    KGB
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KGB Mask, Oxygen, Non-Rebreathing

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