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

    TRANSCUTANEOUS BLOOD OXYGEN SENSOR SYS

    K Number: K830197 · Decision Nov 29, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    46
    Applicant Total
    2
    Review Days
    313

    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
    TRANSCUTANEOUS BLOOD OXYGEN SENSOR SYS
    K Number
    K830197
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2500
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Diamond Shamrock Corp.
    Date Received
    January 20, 1983
    Decision Date
    November 29, 1983
    Product Code
    KLK
    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
    KLK Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia

    Similar 510(k) Clearances

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

    MICROGAS 7650 TRANSCUTANEOUS MONITOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MICROGAS 7650 TRANSCUTANEOUS MONITOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SIEMENS SC9000/SC9015 TCP02/C02 MODULE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    OXYCARE(TM) OXYGEN CONTROLLER/MONITOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    HEWLETT-PACKARD MODEL M1018A TCPO2/TOPCO2 MODULE

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

    Other Clearances by Diamond Shamrock Corp.

    K Number Device Name
    K760262 RADIOASSY KIT, 3H-FOLATE