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

    ECOLYZER #200/COHB ANALYZER SYS

    K Number: K832655 · Decision Sep 26, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    27
    Applicant Total
    632
    Review Days
    49

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    Basic Information

    Device Name
    ECOLYZER #200/COHB ANALYZER SYS
    K Number
    K832655
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1430
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Bd Becton Dickinson Vacutainer Systems Preanalytic
    Date Received
    August 8, 1983
    Decision Date
    September 26, 1983
    Product Code
    CCJ
    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
    CCJ Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase

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