BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR

    K Number: K002846 · Decision Jun 6, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    208
    Applicant Total
    2
    Review Days
    267

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    Basic Information

    Device Name
    HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR
    K Number
    K002846
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5915
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Headstar Medical Products Co., Ltd.
    Date Received
    September 12, 2000
    Decision Date
    June 6, 2001
    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 Headstar Medical Products Co., Ltd.

    K Number Device Name
    K121770 HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZER