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

    BE#6006 VAR. RESIS. INSPIR. MUSCLE

    K Number: K821492 · Decision Sep 24, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    107
    Applicant Total
    45
    Review Days
    129

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    Basic Information

    Device Name
    BE#6006 VAR. RESIS. INSPIR. MUSCLE
    K Number
    K821492
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5690
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Instrumentation Industries, Inc.
    Date Received
    May 18, 1982
    Decision Date
    September 24, 1982
    Product Code
    BWF
    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
    BWF Spirometer, Therapeutic (Incentive)

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