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

    FORE-SIGHT, MC-2000 SERIES

    K Number: K073036 · Decision Feb 25, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    32
    Review Days
    119

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    Basic Information

    Device Name
    FORE-SIGHT, MC-2000 SERIES
    K Number
    K073036
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cas Medical Systems, Inc.
    Date Received
    October 29, 2007
    Decision Date
    February 25, 2008
    Product Code
    DQA
    Advisory Committee
    Cardiovascular
    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
    DQA Oximeter

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    Other Clearances by Cas Medical Systems, Inc.

    K Number Device Name
    K190270 FORE-SIGHT ELITE Tissue Oximeter Module
    K180003 FORE-SIGHT ELITE Module Tissue Oximeter
    K150620 740 SELECT
    K143675 FORE-SIGHT Elite Absolute Tissue Oximeter
    K140430 740 SELECT
    K133879 FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER
    K130411 740 SELECT
    K123700 FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER
    K112820 FORE-SIGHT ABSOLUTE TISSUE OXIMETER
    K094030 FORE-SIGHT ABSOLUTE CEREBRAL AND SOMATIC OXIMETER, MC 2000 SERIES, MODELS MC2000, MC2010, MC2020, MC2030
    Search all 32 clearances from Cas Medical Systems, Inc. →