BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MERCURY MEDICAL REUSABLE CPR BAG

    K Number: K970756 · Decision Oct 31, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    208
    Applicant Total
    15
    Review Days
    242

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    Basic Information

    Device Name
    MERCURY MEDICAL REUSABLE CPR BAG
    K Number
    K970756
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5915
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mercury Medical
    Date Received
    March 3, 1997
    Decision Date
    October 31, 1997
    Product Code
    BTM
    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
    BTM Ventilator, Emergency, Manual (Resuscitator)

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