| Device Type ID | 3637 |
| Device Name | Stimulator, Photic, Evoked Response |
| Regulation Description | Evoked Response Photic Stimulator. |
| 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 | 882.1890 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | GWE |
| 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 | 3637 |
| Device | Stimulator, Photic, Evoked Response |
| Product Code | GWE |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Evoked Response Photic Stimulator. |
| CFR Regulation Number | 882.1890 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
NATUS MEDICAL INCORPORATED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Sparking | 2 |
Electrical /Electronic Property Problem | 2 |
| Total Device Problems | 4 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Natus Medical Incorporated | II | Feb-09-2015 |