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

    CRITICAL CARE VENTILATOR

    K Number: K120931 · Decision Jun 6, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    504
    Applicant Total
    4
    Review Days
    436

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    Basic Information

    Device Name
    CRITICAL CARE VENTILATOR
    K Number
    K120931
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Oricare, Inc.
    Date Received
    March 27, 2012
    Decision Date
    June 6, 2013
    Product Code
    CBK
    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
    CBK Ventilator, Continuous, Facility Use

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    Other Clearances by Oricare, Inc.

    K Number Device Name
    K131790 A9800 ANESTHESIA WORKSTATION
    K122875 ORICARE L2700
    K113338 MEDICAL AIR COMPRESSOR