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

    515A NEO-TRAK NEONATAL MONITOR

    K Number: K861861 · Decision Jul 10, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    46
    Applicant Total
    136
    Review Days
    57

    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
    515A NEO-TRAK NEONATAL MONITOR
    K Number
    K861861
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2500
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Ge Medical Systems Information Technologies
    Date Received
    May 14, 1986
    Decision Date
    July 10, 1986
    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 Ge Medical Systems Information Technologies

    K Number Device Name
    K120770 QT GUARD PLUS ANALYSIS SYSTEM
    K102426 CARESCAPE MODEL V100 VITAL SIGNS MONITOR
    K092369 12SL ECG ANALYSIS PROGRAM
    K093141 MARS HOLTER ANALYSIS WORKSTATION
    K092027 CARESCAPE MONITOR B850
    K090702 MODIFICATION TO DASH 2500 PATIENT MONITOR
    K083750 CAPNOSTAT / CAPNOFLEX CO2 SYSTEM
    K083639 MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE
    K082851 MULTLINK CABLE AND LEADWIRE SYSTEM
    K081437 MAC 1600 ECG ANALYSIS SYSTEM
    Search all 136 clearances from Ge Medical Systems Information Technologies →