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

    PANDA HELIUM GAS ANALYZER

    K Number: K903939 · Decision Jan 3, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    2
    Applicant Total
    6
    Review Days
    129

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    Basic Information

    Device Name
    PANDA HELIUM GAS ANALYZER
    K Number
    K903939
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1640
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Medical Associated Services, Inc.
    Date Received
    August 27, 1990
    Decision Date
    January 3, 1991
    Product Code
    BSE
    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
    BSE Analyzer, Gas, Helium, Gaseous-Phase

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