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

    HSINER RESUSCITATOR

    K Number: K053466 · Decision Mar 22, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    208
    Applicant Total
    7
    Review Days
    99

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    Basic Information

    Device Name
    HSINER RESUSCITATOR
    K Number
    K053466
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    868.5915
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hsiner Co., Ltd.
    Date Received
    December 13, 2005
    Decision Date
    March 22, 2006
    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 Hsiner Co., Ltd.

    K Number Device Name
    K251888 VPAP Pediatric Face Mask
    K102120 NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK MODEL 10212, 10222, 10202
    K091185 70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER
    K082009 HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS
    K063268 CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235
    K052811 HSINER JET NEBULIZER, MODEL HS-31100