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

    SMI 3000 AIRBED

    K Number: K883192 · Decision Oct 26, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    56
    Applicant Total
    1
    Review Days
    90

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    SMI 3000 AIRBED
    K Number
    K883192
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5170
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Smi Patientcare, Inc.
    Date Received
    July 28, 1988
    Decision Date
    October 26, 1988
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (IOQ), ordered by most recent decision date.

    Hill-Rom Wireless Connectivity Module

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    NURSE'S AID PATIENT ROTATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    HYDROTEC LOW AIR LOSS THERAPY BED

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    AIRTEC2 LOW AIR LOSS THERAPY BED

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    TOTALCARE., MODULAR THERAPY SYSTEM (MTS)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine
    View all