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

    CRITERION, CRITERION I.V., MODIFIED

    K Number: K952267 · Decision Dec 2, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    45
    Applicant Total
    12
    Review Days
    932

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    Basic Information

    Device Name
    CRITERION, CRITERION I.V., MODIFIED
    K Number
    K952267
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5270
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Nova-Ventrx
    Date Received
    May 15, 1995
    Decision Date
    December 2, 1997
    Product Code
    BZE
    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
    BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

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    Other Clearances by Nova-Ventrx

    K Number Device Name
    K954480 CONDENSATE COLLECTION KIT
    K893760 CRITERION I.V. VENTILATOR BREATHING CIRCUIT #1004
    K881207 RES-Q 1, 2, 3, 4 AND 5
    K870382 DRV DISP RESUSCIT 3000/BAG ADAPT 3010 & 3011
    K863756 MODIFIED CRITERION VENTILATOR BREATHING CIRCUIT
    K850600 CO-AX VENTILATOR CIRCUIT
    K842794 MAXI-MISER HUMIDIFIER INSERT 1020 & 1021
    K842795 MAXI-MISER HUMIDIFIER INSERT 1030
    K841571 MAXI-MISER WATER TRANSFER SET 1021/1022
    K841569 MAXI-MISER HUMIDIFIER INSERT 1020
    Search all 12 clearances from Nova-Ventrx →