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

    BIOCHEM 520 BREATH INDICATOR

    K Number: K890874 · Decision Jun 15, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    217
    Registration Numbers
    217
    Same Product Code
    304
    Applicant Total
    28
    Review Days
    114

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    Basic Information

    Device Name
    BIOCHEM 520 BREATH INDICATOR
    K Number
    K890874
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1400
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Biochem International, Inc.
    Date Received
    February 21, 1989
    Decision Date
    June 15, 1989
    Product Code
    CCK
    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
    CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

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    K910381 BIOCHEM TEMPERATURE/ FIO2 MODULE
    K911351 BIOCHEM 9100 MULTIGAS MONITOR TEMP/FIO1 MOD,NIBP
    K903222 BIOCHEM 6100 NON-INVASIVE MONITOR
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