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

    THERA-TURN CM-1000 MATTRESS OVERLAY SYSTEM

    K Number: K931594 · Decision Dec 21, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    56
    Applicant Total
    30
    Review Days
    265

    Basic Information

    Device Name
    THERA-TURN CM-1000 MATTRESS OVERLAY SYSTEM
    K Number
    K931594
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5170
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    MEDICAL DEVICE INSPECTION CO., INC.
    Date Received
    March 31, 1993
    Decision Date
    December 21, 1993
    Product Code
    IOQ
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IOQ Bed, Flotation Therapy, Powered

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