BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    PNEUMOTACHOGRAPHY SYSTEM

    K Number: K760816 · Decision Oct 29, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    17

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    Basic Information

    Device Name
    PNEUMOTACHOGRAPHY SYSTEM
    K Number
    K760816
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3740
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Aftercal, Inc.
    Date Received
    October 12, 1976
    Decision Date
    October 29, 1976
    Product Code
    GWB
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GWB Antisera, Fluorescent, All Types, Streptococcus Pneumoniae

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