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

    BIO-TEK PERCENT OXYGEN MONITOR 74222

    K Number: K831522 · Decision Sep 12, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    82
    Registration Numbers
    82
    Same Product Code
    120
    Applicant Total
    37
    Review Days
    123

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    Basic Information

    Device Name
    BIO-TEK PERCENT OXYGEN MONITOR 74222
    K Number
    K831522
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1720
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Bio-Tek Instruments, Inc.
    Date Received
    May 12, 1983
    Decision Date
    September 12, 1983
    Product Code
    CCL
    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
    CCL Analyzer, Gas, Oxygen, Gaseous-Phase

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