BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent - Subject to Tracking Reg. 🇺🇸 United States

    BABYBIRD VENTILATOR, PORTABLE LIFECARE VENTILATOR, EXTERNAL PRESSURE LIMITER, VOLUME VENTILATOR WITH PRESSURE LIMIT

    K Number: K972203 · Decision Nov 6, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    504
    Applicant Total
    26
    Review Days
    148

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    Basic Information

    Device Name
    BABYBIRD VENTILATOR, PORTABLE LIFECARE VENTILATOR, EXTERNAL PRESSURE LIMITER, VOLUME VENTILATOR WITH PRESSURE LIMIT
    K Number
    K972203
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent - Subject to Tracking Reg.
    Applicant
    Allied Healthcare Products, Inc.
    Date Received
    June 11, 1997
    Decision Date
    November 6, 1997
    Product Code
    CBK
    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
    CBK Ventilator, Continuous, Facility Use

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    Other Clearances by Allied Healthcare Products, Inc.

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