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

    MODEL M25RL, (CRC) OXYGEN ANALYZER

    K Number: K790785 · Decision Apr 27, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    82
    Registration Numbers
    82
    Same Product Code
    120
    Applicant Total
    9
    Review Days
    4

    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
    MODEL M25RL, (CRC) OXYGEN ANALYZER
    K Number
    K790785
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1720
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Catalyst Research Corp.
    Date Received
    April 23, 1979
    Decision Date
    April 27, 1979
    Product Code
    CCL
    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
    CCL Analyzer, Gas, Oxygen, Gaseous-Phase

    Similar 510(k) Clearances

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

    OxyMinder Pro (10310)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Smart Check O2 (MA0236)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Maxtec MaxO2 ME+p

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Percent Oxygen Sensors

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    OxyMinder

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Accu O2 Oxygen Analyzer

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

    Other Clearances by Catalyst Research Corp.

    K Number Device Name
    K905310 MINIOX V PULSE OXIMETER
    K874132 MINIOX IV PORTABLE PULSE OXIMETER
    K862798 MINIOX 100 PULSE OXIMETER
    K833995 MINI OX II
    K833326 MINI OX III OXYGEN MONITOR
    K790784 MODEL M25R, OXYGEN ANALYZER
    K782062 ANALYZER, OXYGEN MODEL M25RA & M25RAD
    K781746 MINICO