| Device Type ID | 3645 |
| Device Name | Nystagmograph |
| Regulation Description | Nystagmograph. |
| 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 | 882.1460 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | GWN |
| 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 | 3645 |
| Device | Nystagmograph |
| Product Code | GWN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Nystagmograph. |
| CFR Regulation Number | 882.1460 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
GN OTOMETRICS A/S | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INTERACOUSTICS A/S | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
NEURO KINETICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SYNCTHINK, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WILLIAM DEMANT HOLDING A/S | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Integra LifeSciences Corp. | II | Jul-17-2014 |
| 2 | Neuro Kinetics, Inc. | II | Sep-03-2015 |
| 3 | Neuro Kinetics, Inc. | II | Jun-12-2015 |
| 4 | Neuro Kinetics, Inc. | II | Feb-10-2014 |