| Device Type ID | 3677 |
| Device Name | Transducer, Tremor |
| Regulation Description | Tremor Transducer. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurodiagnostic And Neurosurgical Devices Branch (NDNB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 882.1950 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | GYD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 3677 |
| Device | Transducer, Tremor |
| Product Code | GYD |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Tremor Transducer. |
| CFR Regulation Number | 882.1950 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
GKC MANUFACTURING PTY LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |