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

    epoc Blood Analysis System

    K Number: K200107 · Decision Jun 5, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    187
    Applicant Total
    7
    Review Days
    140

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    Basic Information

    Device Name
    epoc Blood Analysis System
    K Number
    K200107
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.1120
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Epocal, Inc.
    Date Received
    January 17, 2020
    Decision Date
    June 5, 2020
    Product Code
    CHL
    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
    CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph

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    Other Clearances by Epocal, Inc.

    K Number Device Name
    K171247 epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test
    K113726 EPOC CHLORIDE TEST AND EPOC CREATININE TEST
    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
    K061597 EPOC BLOOD ANALYSIS SYSTEM