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

    COMPRESSOR, AIR, PORTABLE

    K Number: K813311 · Decision Dec 31, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    72
    Registration Numbers
    72
    Same Product Code
    73
    Applicant Total
    2
    Review Days
    37

    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
    COMPRESSOR, AIR, PORTABLE
    K Number
    K813311
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.6250
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    The Biomed Group
    Date Received
    November 24, 1981
    Decision Date
    December 31, 1981
    Product Code
    BTI
    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
    BTI Compressor, Air, Portable

    Similar 510(k) Clearances

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

    OMBRA TABLE TOP COMPRESSOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MEDICAL AIR COMPRESSOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DK50 DS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    EMG TRITON -COMP,MODEL NCA01-XXX SERIES

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MEDICAL COMPRESSOR, MODELS DK50 D AND DM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MINIMATE COMPRESSOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology
    View all

    Other Clearances by The Biomed Group

    K Number Device Name
    K810272 BIO CARE OXYGEN CONCENTRATOR