BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    MOTION WATCH AND PRO-DIARY

    K Number: K132764 · Decision Jan 21, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    18
    Applicant Total
    2
    Review Days
    139

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    Basic Information

    Device Name
    MOTION WATCH AND PRO-DIARY
    K Number
    K132764
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5050
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Camntech, Ltd.
    Date Received
    September 4, 2013
    Decision Date
    January 21, 2014
    Product Code
    LEL
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LEL Device, Sleep Assessment

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    Other Clearances by Camntech, Ltd.

    K Number Device Name
    K100266 ACTIWAVE 1E, ACTIWAVE2E, ACTIWAVE2M, ACTIWAVE4E, ACTIWAVE CARDIO MODEL 08-514, 08-521, 08-536, 08-557, 08-603