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

    VERSALET 7700 CARE CENTER, MODEL # 7700

    K Number: K993051 · Decision Feb 3, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    81
    Applicant Total
    5
    Review Days
    143

    Basic Information

    Device Name
    VERSALET 7700 CARE CENTER, MODEL # 7700
    K Number
    K993051
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5400
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    HILL-ROM AIR-SHIELDS
    Date Received
    September 13, 1999
    Decision Date
    February 3, 2000
    Product Code
    FMZ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FMZ Incubator, Neonatal

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