BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    EPOC BLOOD ANALYSIS SYSTEM

    K Number: K061597 · Decision Sep 27, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    161
    Applicant Total
    7
    Review Days
    111

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    Basic Information

    Device Name
    EPOC BLOOD ANALYSIS SYSTEM
    K Number
    K061597
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1665
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Epocal, Inc.
    Date Received
    June 8, 2006
    Decision Date
    September 27, 2006
    Product Code
    JGS
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JGS Electrode, Ion Specific, Sodium

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    Other Clearances by Epocal, Inc.

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    K093297 EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE
    K092849 BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER
    K090109 BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD