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

    DK50 DS

    K Number: K091871 · Decision Oct 23, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    72
    Registration Numbers
    72
    Same Product Code
    73
    Applicant Total
    2
    Review Days
    122

    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
    DK50 DS
    K Number
    K091871
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.6250
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ekom S.R.O.
    Date Received
    June 23, 2009
    Decision Date
    October 23, 2009
    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

    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

    VENTILAIR II MEDICAL AIR COMPRESSOR

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

    Other Clearances by Ekom S.R.O.

    K Number Device Name
    K060781 MEDICAL COMPRESSOR, MODELS DK50 D AND DM