Stimulator, Photic, Evoked Response
Regulation 882.1890
0510(k)s in 12 months (49 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in GWE
| Company | 510(k)s | Recalls |
|---|---|---|
| Bio-Logic Systems Corp. | 4 | 0 |
| Diopsys, Inc. | 2 | 2 |
| Teca, Inc. | 4 | 0 |
| Cadwell Laboratories, Inc. | 2 | 0 |
| Excel Tech. , Ltd. | 2 | 0 |
| Metrovision | 2 | 0 |
| Nihon Kohden America, Inc. | 2 | 0 |
| Tracor Northern, Inc. | 2 | 0 |
| Airsep Corp. | 1 | 0 |
| Amplaid USA, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 9, 2015 | Natus Medical Incorporated EPWorks software used in the Protektor 32
Product Usage:
Uses electroencephalography (EEG), evoked potentials (EP), electromyography (EMG) and transcranial motor evoked potentials (TcMEP) stimulation Terminated |
GWE | K093304 |
| Apr 26, 2010 | Diopsys, Inc. Diopsys Inc., Enfant Pediatric VEP Vision Testing System,
Input: 120 Vac, 60Hz/2.5A IEC 60601-1 Class I, Type BF. Terminated |
GWE | K043491 |
| Nov 6, 2004 | Diopsys Inc The Enfant Evoked Response Photic Stimulator. The Enfant A Pediatric Vision Testing Device, Manufactured by Diopsys, Inc., 355 Main St., Metuchen, NJ 08840. Each medical device unit is assembled an Terminated |
GWE | K880773 |
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