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

    GS-MODULAR (GOLD STANDARD - MODULAR)

    K Number: K925459 · Decision Feb 4, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    227
    Applicant Total
    14
    Review Days
    463

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    Basic Information

    Device Name
    GS-MODULAR (GOLD STANDARD - MODULAR)
    K Number
    K925459
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1840
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Warren E. Collins, Inc.
    Date Received
    October 29, 1992
    Decision Date
    February 4, 1994
    Product Code
    BZG
    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
    BZG Spirometer, Diagnostic

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