BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    PMX COMPACT RESUCITATOR

    K Number: K021390 · Decision Oct 4, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    208
    Applicant Total
    6
    Review Days
    155

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    Basic Information

    Device Name
    PMX COMPACT RESUCITATOR
    K Number
    K021390
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5915
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Cheen Houng Ent. Co. , Ltd.
    Date Received
    May 2, 2002
    Decision Date
    October 4, 2002
    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 Cheen Houng Ent. Co. , Ltd.

    K Number Device Name
    K121587 BREATH SHAKE
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    K010191 Y2000 POCKET RESCUE
    K981415 0-20 CM H20 PEEP VALVE
    K970688 POCKET RESCUE