BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    DRAGER ORM

    K Number: K790334 · Decision Mar 7, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    2
    Applicant Total
    78
    Review Days
    19

    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
    DRAGER ORM
    K Number
    K790334
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.2875
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Draeger Medical, Inc.
    Date Received
    February 16, 1979
    Decision Date
    March 7, 1979
    Product Code
    BYR
    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
    BYR Transducer, Gas Pressure, Differential

    Similar 510(k) Clearances

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

    BICORE VARIFLEX(R) FLOW TRANSDUCER

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    MMI/GAELTEC SERIES 8T DIFF. PRESS. TRANS

    FDA 510(k)
    FDA Class 1 ·Anesthesiology
    View all

    Other Clearances by Draeger Medical, Inc.

    K Number Device Name
    K042607 PRIMUS US
    K042419 FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEM
    K042276 D-VAPOR
    K042086 FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM
    K041622 MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM
    K040847 MODIFICATION TO VAMOS ANESTHETIC GAS MONITOR
    K033498 NARKOMED 6400, MODEL NM6400
    K030624 MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM
    K031400 FABIUS TIRO ANESTHESIA SYSTEM
    K022031 NARKOMED MRI-2 ANESTHESIA SYSTEM, MODEL NM-MRI-2
    Search all 78 clearances from Draeger Medical, Inc. →