Nystagmograph
Regulation 882.1460
1510(k)s in 12 months (60 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in GWN
| Company | 510(k)s | Recalls |
|---|---|---|
| Neuro Kinetics | 4 | 3 |
| Interacoustics A/S | 5 | 0 |
| Ics Medical | 3 | 0 |
| Micromedical Technologies, Inc. | 3 | 0 |
| Philadelphia Medical Specialties | 3 | 0 |
| Bio-Logic Systems Corp. | 2 | 0 |
| Fall Prevention Technologies, LLC | 2 | 0 |
| Gn Otometrics | 2 | 0 |
| Kelleher Corp. | 2 | 0 |
| Synapsys SA | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 3, 2015 | Neuro Kinetics, Inc. Neuro Kinetics, Inc. (NKI) I-Portal NOTC system with the OVAR research test; a rotary chair system used in vestibular and neuro-otologic diagnostic testing. This device provides no diagnoses nor does Terminated |
GWN | K083603 K143607 |
| Jun 12, 2015 | Neuro Kinetics, Inc. I-Portal NOTC and VNG; a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball, indicated for use as a diagnostic tool to assist trained clinicians i Terminated |
GWN | K083603 |
| Jul 17, 2014 | Integra LifeSciences Corp. Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters,
Cat. No's. 110-4B, 110-4G, 110-4H, 110-4L Terminated |
GWN | K102875 |
| Feb 10, 2014 | Neuro Kinetics, Inc. Normative Data Template CD for use with the I-Portal devices.
Used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball. Terminated |
GWN | K083603 |
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