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

    PREEMICARE MODEL 200-II INFANT TRANSPORT VENTIL.

    K Number: K893622 · Decision Jan 3, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    504
    Applicant Total
    9
    Review Days
    237

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    Basic Information

    Device Name
    PREEMICARE MODEL 200-II INFANT TRANSPORT VENTIL.
    K Number
    K893622
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Preemicare Corp.
    Date Received
    May 11, 1989
    Decision Date
    January 3, 1990
    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 Preemicare Corp.

    K Number Device Name
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    K896375 PREEMICARE NEBUTECH NEBULIZER SYSTEM
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    K893624 PREEMICARE MODEL 2500 TRANSPORT WARMER
    K891674 NEONATAL ENVIRONMENTAL MONITOR, MODEL 275
    K885350 PREEMICARE SERIES 2000 INFANT WARMER
    K884133 PREEMICARE SERIES 4000 PHOTOTHERAPY LAMP
    K881476 PREEMICARE MODEL D1-X1, SERIES 3000