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

    CLINICAL DATA APNEA DETECTOR

    K Number: K821721 · Decision Jul 13, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    15
    Applicant Total
    36
    Review Days
    33

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    Basic Information

    Device Name
    CLINICAL DATA APNEA DETECTOR
    K Number
    K821721
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2377
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Clinical Data, Inc.
    Date Received
    June 10, 1982
    Decision Date
    July 13, 1982
    Product Code
    FLS
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FLS Monitor, Apnea, Facility Use

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