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

    DYNASENSE SYSTEM

    K Number: K130752 · Decision Aug 15, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    30
    Applicant Total
    1
    Review Days
    149

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    Basic Information

    Device Name
    DYNASENSE SYSTEM
    K Number
    K130752
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.2400
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Centauri Medical, Inc.
    Date Received
    March 19, 2013
    Decision Date
    August 15, 2013
    Product Code
    KMI
    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
    KMI Monitor, Bed Patient

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