Amplitude-Integrated Electroencephalograph
Regulation 882.1400
0510(k)s in 12 months (16 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in OMA
| Company | 510(k)s | Recalls |
|---|---|---|
| Moberg Research, Inc. | 1 | 1 |
| Natus Neurology DBA Excel Tech., Ltd. (XLTEK) | 0 | 2 |
| Nihon Kohden Corp. | 2 | 0 |
| Nihon Kohden America, Inc. | 2 | 0 |
| Olympic Medical Corp. | 2 | 0 |
| Applied Medical Research | 1 | 0 |
| Astro-Med, Inc. | 1 | 0 |
| Brainz Instruments , Ltd. | 1 | 0 |
| Cadwell Industries, Inc. | 1 | 0 |
| Eemagine Medical Imaging Solutions GmbH | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 9, 2025 | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) Brand Name: OBM00002 OBM DAB (Digital Acquisition Box)
Product Name: OBM00002 OBM DAB (Digital Acquisition Box)
Model/Catalog Number: OBM00002 OBM DAB (Digital Acquisition Box)
Software Version: N/A
P Open, Classified |
OMA | K123079 |
| Apr 4, 2023 | Moberg Research, Inc. Moberg Component Neuromonitoring System (CNS Monitor)-Intended as a short-term neurological monitoring system that collects, displays, and stores multiple physiological measurements
Model: CNS-350 Open, Classified |
OMA | K080217 |
| Apr 1, 2020 | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph Terminated |
OMA | K123079 |
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