Automatic Event Detection Software For Full-Montage Electroencephalograph
Regulation 882.1400
2510(k)s in 12 months (42 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in OMB
| Company | 510(k)s | Recalls |
|---|---|---|
| Persyst Development Corp. | 9 | 0 |
| Ceribell, Inc. | 5 | 0 |
| Excel Tech. , Ltd. | 3 | 0 |
| Ait Austrian Institute of Technology GmbH | 2 | 0 |
| Epitel, Inc. | 2 | 0 |
| Holberg Eeg AS | 2 | 0 |
| LVIS Corporation | 2 | 0 |
| Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2 | 0 |
| New England Medical Instruments, Inc. | 2 | 0 |
| Optima Neuroscience, Inc. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 2, 2021 | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software Terminated |
OMB | K090019 K090277 |
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