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

    ACMI ASPIRATOR KIT #8808

    K Number: K811218 · Decision Jul 1, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    238
    Applicant Total
    9
    Review Days
    58

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    Basic Information

    Device Name
    ACMI ASPIRATOR KIT #8808
    K Number
    K811218
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4680
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    American Cystocope Makers, Inc.
    Date Received
    May 4, 1981
    Decision Date
    July 1, 1981
    Product Code
    EOQ
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EOQ Bronchoscope (Flexible Or Rigid)

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    Other Clearances by American Cystocope Makers, Inc.

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    K791182 ACMI RIGI-FLEX NEPHORSCOPE
    K770754 DUODENOSCOPE, MOLEL TX-6
    K760822 MODEL TX-8 PANENDOSCOPE
    K760452 COLONOSCOPE, 2-CHANNEL LOG (ACMI TX-92)
    K760451 AIR WATER SOURCE (ACMI MODEL 710)