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

    RESUSCITATION MASK

    K Number: K820059 · Decision Mar 26, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    208
    Applicant Total
    7
    Review Days
    74

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    Basic Information

    Device Name
    RESUSCITATION MASK
    K Number
    K820059
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5915
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Cederroth, Inc. USA
    Date Received
    January 11, 1982
    Decision Date
    March 26, 1982
    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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    Other Clearances by Cederroth, Inc. USA

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    K813365 MULTIPLE BANDAGE OR DRESSING
    K813364 MEDICAL TAPE (MULTIPLE)
    K813361 ADHESIVE STRIP(MULTIPLE)