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 |