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

    72 HOUR USE TRACH CARE WITH MICROBAN

    K Number: K974630 · Decision Mar 11, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    141
    Registration Numbers
    141
    Same Product Code
    201
    Applicant Total
    26
    Review Days
    89

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    Basic Information

    Device Name
    72 HOUR USE TRACH CARE WITH MICROBAN
    K Number
    K974630
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5260
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ballard Medical Products
    Date Received
    December 12, 1997
    Decision Date
    March 11, 1998
    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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