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

    AEROSOL DELIVERY SYSTEM (AERO-TECH II)

    K Number: K873930 · Decision Dec 7, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    507
    Applicant Total
    6
    Review Days
    73

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    Basic Information

    Device Name
    AEROSOL DELIVERY SYSTEM (AERO-TECH II)
    K Number
    K873930
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5630
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Cadema Medical Products, Inc.
    Date Received
    September 25, 1987
    Decision Date
    December 7, 1987
    Product Code
    CAF
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    RA
    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 Cadema Medical Products, Inc.

    K Number Device Name
    K901476 MODIFIED ENTRAPPING FILTER
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    K800023 LUNG AEROSOL UNIT