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

    DISPOSABLE BACTERIA FILTER

    K Number: K770136 · Decision Feb 14, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    141
    Registration Numbers
    141
    Same Product Code
    201
    Applicant Total
    10
    Review Days
    21

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    Basic Information

    Device Name
    DISPOSABLE BACTERIA FILTER
    K Number
    K770136
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5260
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Omnicon Medical Corp.
    Date Received
    January 24, 1977
    Decision Date
    February 14, 1977
    Product Code
    CAH
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CAH Filter, Bacterial, Breathing-Circuit

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    Other Clearances by Omnicon Medical Corp.

    K Number Device Name
    K823872 EMERGENCY TRACHEOSTOMY KIT
    K820577 ANESTHESIA BACTERIA FILTER
    K820576 MAINFLOW BACTERIA FILTER
    K801804 ANESTHESIA BACTERIA FILTER
    K801803 MAINFLOW BACTERIA FILTER
    K772060 PROTECT IV GARD
    K770001 AIRWAY, BERMAN 40, 60, 80, 90, L00MM'S
    K760819 CONDUCTIVE ANESTHESIA BREATHING CIRCUIT
    K760149 CONDUCTIVE ANESTHSIA BREATH. CIRCUIT