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

    CRY-ACTRACKERCAM

    K Number: K110305 · Decision Jan 13, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    13
    Applicant Total
    1
    Review Days
    345

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    Basic Information

    Device Name
    CRY-ACTRACKERCAM
    K Number
    K110305
    Device Class
    FDA class 1
    Clearance Type
    Special
    Regulation Number
    880.2900
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Brymill Cryogenic Cystems
    Date Received
    February 2, 2011
    Decision Date
    January 13, 2012
    Product Code
    FQZ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FQZ Thermometer, Clinical Color Change

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