Index-Generating Electroencephalograph Software
Regulation 882.1400
2510(k)s in 12 months (40 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in OLW
| Company | 510(k)s | Recalls |
|---|---|---|
| Aspect Medical Systems, Inc. | 12 | 0 |
| Physiometrix, Inc. | 4 | 0 |
| Covidien LP | 2 | 1 |
| GE Healthcare | 3 | 0 |
| Masimo Corporation | 3 | 0 |
| Datex-Ohmeda | 2 | 0 |
| Mennen Medical , Ltd. | 2 | 0 |
| Spacelabs Medical, Inc. | 2 | 0 |
| Agilent Technologies Deutschland GmbH | 1 | 0 |
| Alaris Medical Systems, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 26, 2018 | Covidien LLC Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems.
Product Number/CFN: 186-0208
UDI-Device Identifier (GTIN/UPN): 10884521130319 Open, Classified |
OLW | K072286 |
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