BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent - Subject to Tracking Reg. 🇺🇸 United States

    OMICRON MONITOR, DELTA MONITOR

    K Number: K960861 · Decision Aug 19, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    504
    Applicant Total
    3
    Review Days
    171

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    Basic Information

    Device Name
    OMICRON MONITOR, DELTA MONITOR
    K Number
    K960861
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent - Subject to Tracking Reg.
    Applicant
    Core-M, Inc.
    Date Received
    March 1, 1996
    Decision Date
    August 19, 1996
    Product Code
    CBK
    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
    CBK Ventilator, Continuous, Facility Use

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    Other Clearances by Core-M, Inc.

    K Number Device Name
    K921978 BREATH TRACKER(TM) MODEL 1800 CAN-O-GAUGE
    K892942 BREATH TRACKER