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

    1ST RESPONSE REUSABLE MANUAL RESUSCITATOR (ADULT)

    K Number: K900577 · Decision Jul 16, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    208
    Applicant Total
    29
    Review Days
    159

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    Basic Information

    Device Name
    1ST RESPONSE REUSABLE MANUAL RESUSCITATOR (ADULT)
    K Number
    K900577
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5915
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Intertech Resources, Inc.
    Date Received
    February 7, 1990
    Decision Date
    July 16, 1990
    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 Intertech Resources, Inc.

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    K952062 PFT FILTER
    K952169 SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRIC
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    K935036 HEPA FILTERED HEAT AND MOISTURE EXCHANGER
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