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

    COMOACT ULTRASONIC NEBULIZER, MODEL 3060

    K Number: K002543 · Decision Jun 14, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    187
    Registration Numbers
    188
    Same Product Code
    503
    Applicant Total
    2
    Review Days
    302

    Basic Information

    Device Name
    COMOACT ULTRASONIC NEBULIZER, MODEL 3060
    K Number
    K002543
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5630
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    SAN UP S.A.
    Date Received
    August 16, 2000
    Decision Date
    June 14, 2001
    Product Code
    CAF
    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
    CAF Nebulizer (Direct Patient Interface)

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    Other Clearances by SAN UP S.A.

    K Number Device Name
    K002468 SAN UP S.A. NEBULIZER COMPRESSOR, WITH DISPOSABLE NEBULIZER, MODEL 3050