Standard Polysomnograph With Electroencephalograph
Regulation 882.1400
2510(k)s in 12 months (65 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in OLV
| Company | 510(k)s | Recalls |
|---|---|---|
| Nihon Kohden America, Inc. | 9 | 0 |
| Neurotronics, Inc. | 5 | 0 |
| Grass-Telefactor Product Group | 4 | 0 |
| Bio-Logic Systems Corp. | 3 | 0 |
| Airsep Corp. | 2 | 0 |
| Astro-Med, Inc. | 2 | 0 |
| Biosys AB (Publ) | 2 | 0 |
| Compumedics Limited | 2 | 0 |
| Excel Tech. , Ltd. | 2 | 0 |
| Grass Instrument Co. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 1, 2018 | Natus Neurology Inc Nicolet Ambulatory EEG Terminated |
OLV | K021185 |
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