BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    SMARTVENT 201 PORTABLE VENTILATOR

    K Number: K981668 · Decision Apr 7, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    504
    Applicant Total
    3
    Review Days
    331

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    Basic Information

    Device Name
    SMARTVENT 201 PORTABLE VENTILATOR
    K Number
    K981668
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Versamed , Ltd.
    Date Received
    May 11, 1998
    Decision Date
    April 7, 1999
    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 Versamed , Ltd.

    K Number Device Name
    K021981 IVENT 201 PORTABLE VENTILATOR
    K011957 IVENT 201 PORTABLE VENTILATOR