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

    NEUROVISION MEDICAL MOTION SENSOR

    K Number: K130570 · Decision Dec 26, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    109
    Registration Numbers
    109
    Same Product Code
    174
    Applicant Total
    9
    Review Days
    297

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    Basic Information

    Device Name
    NEUROVISION MEDICAL MOTION SENSOR
    K Number
    K130570
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2375
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neurovision Medical Products, Inc.
    Date Received
    March 4, 2013
    Decision Date
    December 26, 2013
    Product Code
    BZQ
    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
    BZQ Monitor, Breathing Frequency

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    Other Clearances by Neurovision Medical Products, Inc.

    K Number Device Name
    K130806 NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE
    K113771 SIGNAL GEAR URETHRAL CATHETER ELECTRODE
    K121931 NONDISPOSABLE STIMULATING INSTRUMENTS
    K110989 NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE
    K110140 NEUROVISION NERVE LOCATOR MONITOR
    K110712 DRYTOUCH SUCTION STIMULATOR PROBE
    K110138 PAIRED HYDROGEL ELECTRODE
    K102862 NEUROVISION SE (NERVEANA)