Device Type ID | 3843 |
Device Name | Stimulator, Vestibular Acceleration, Therapeutic |
Review Panel | Neurology |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurostimulation Devices Neurology Branch (NSDN) |
Submission Type | Contact ODE |
FDA Device Classification | Class 3 Medical Device |
Product Code | MHZ |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 3843 |
Device | Stimulator, Vestibular Acceleration, Therapeutic |
Product Code | MHZ |
FDA Device Classification | Class 3 Medical Device |
Recalls | |||
---|---|---|---|
Manufacturer | Recall Class | Date Posted | |
1 | GE Healthcare, LLC | II | Nov-29-2018 |