Stimulator, Vestibular Acceleration, Therapeutic

Device Code: 3843

Product Code(s): MHZ

Device Classification Information

Device Type ID3843
Device NameStimulator, Vestibular Acceleration, Therapeutic
Review PanelNeurology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Neurological And Physical Medicine Devices (DNPMD)
Neurostimulation Devices Neurology Branch (NSDN)
Submission TypeContact ODE
FDA Device ClassificationClass 3 Medical Device
Product CodeMHZ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3843
DeviceStimulator, Vestibular Acceleration, Therapeutic
Product CodeMHZ
FDA Device ClassificationClass 3 Medical Device
Recalls
Manufacturer Recall Class Date Posted
1
GE Healthcare, LLC
II Nov-29-2018
TPLC Last Update: 2019-04-02 20:38:40

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