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

    RONDEX MASK MODELS 9122/9111/9102/911102, MODIFIED

    K Number: K921002 · Decision Oct 6, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    208
    Applicant Total
    11
    Review Days
    224

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    Basic Information

    Device Name
    RONDEX MASK MODELS 9122/9111/9102/911102, MODIFIED
    K Number
    K921002
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5915
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rondex Products, Inc.
    Date Received
    February 25, 1992
    Decision Date
    October 6, 1992
    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 Rondex Products, Inc.

    K Number Device Name
    K981169 RONDEX CPR ISO-SHIELD
    K942671 CPR SHIELD
    K943761 NON-BREATHING VALVE
    K914195 RONDEX CPR NON REBREATHING VALVE #9030, MODIFIED
    K914196 RONDEX MASKS MODELS 9015/9011/901102 MODIFIED
    K902299 CPR VALVE (NON-REBREATHING) MODEL #9030
    K902298 ORAL-NASAL MASK RESUSCITATION AND ANESTHETIC GAS
    K881931 RESCUE MASK & CPR VALVE FOR MOUTH-TO-MASK TYPE CPR
    K881393 RONDEX RESCUE MASK
    K834250 RESCUE MASK
    Search all 11 clearances from Rondex Products, Inc. →