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

    HEMOGASTAT

    K Number: K801148 · Decision Jun 9, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    27

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    Basic Information

    Device Name
    HEMOGASTAT
    K Number
    K801148
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2050
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Therapac, Inc.
    Date Received
    May 13, 1980
    Decision Date
    June 9, 1980
    Product Code
    JRR
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JRR Regulator, Temperature

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