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

    FADASSI MEDICAL FM-1 NO BLENDER

    K Number: K003665 · Decision Feb 23, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    3
    Applicant Total
    2
    Review Days
    87

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    Basic Information

    Device Name
    FADASSI MEDICAL FM-1 NO BLENDER
    K Number
    K003665
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5165
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fadasis Medical, Inc.
    Date Received
    November 28, 2000
    Decision Date
    February 23, 2001
    Product Code
    MRO
    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
    MRO Apparatus, Nitric Oxide, Backup Delivery

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    Other Clearances by Fadasis Medical, Inc.

    K Number Device Name
    K011874 FADASIS MEDICAL FM-1 NO BLENDER