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

    COMPANION RETROFIT OXYGEN CONCENTRATION INDICATOR

    K Number: K920338 · Decision Aug 27, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    82
    Registration Numbers
    82
    Same Product Code
    120
    Applicant Total
    110
    Review Days
    216

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    Basic Information

    Device Name
    COMPANION RETROFIT OXYGEN CONCENTRATION INDICATOR
    K Number
    K920338
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1720
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Puritan Bennett Corp.
    Date Received
    January 24, 1992
    Decision Date
    August 27, 1992
    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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