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

    OMNI-TRAK (PATIENT MONITOR)

    K Number: K890817 · Decision Aug 10, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    217
    Registration Numbers
    217
    Same Product Code
    304
    Applicant Total
    14
    Review Days
    174

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    Basic Information

    Device Name
    OMNI-TRAK (PATIENT MONITOR)
    K Number
    K890817
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1400
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Invivo Research, Inc.
    Date Received
    February 17, 1989
    Decision Date
    August 10, 1989
    Product Code
    CCK
    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
    CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

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    Other Clearances by Invivo Research, Inc.

    K Number Device Name
    K050399 MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 3160
    K043354 MODULAR TELEMETRY SYSTEM FOR THE VISION TELEPAK, MODEL 20701
    K041918 INTEGRATED PATIENT MONITORING SYSTEM
    K040915 MAGNITUDE 3150M MRI PATIENT MONITOR, MODEL 3150M
    K002604 CENTURION 2000 CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM
    K002030 OMNI-TRAK 3150/3155A SERIES MONITOR WITH ANESTHETIC AGENT, MODEL 3155A SERIES
    K980045 CENTURION CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM
    K974581 MILLENNIA 3500 SERIES MONITOR WITH ANTHESTHETIC AGENT
    K971840 OMNI-TRAK MODEL 3150 SERIES PATIENT MONITORING SYSTEM
    K955045 OMNI-TRAK PATIENT MONITORING SYSTEM
    Search all 14 clearances from Invivo Research, Inc. →