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

    RESPA-TROL

    K Number: K810107 · Decision Jan 26, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    66
    Applicant Total
    12
    Review Days
    10

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    Basic Information

    Device Name
    RESPA-TROL
    K Number
    K810107
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Intensive Technology, Inc.
    Date Received
    January 16, 1981
    Decision Date
    January 26, 1981
    Product Code
    JJS
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JJS Controls For Blood-Gases, (Assayed And Unassayed)

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