Physiological Signal Based Seizure Monitoring System
Regulation 882.1580
1510(k)s in 12 months (10 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in POS
| Company | 510(k)s | Recalls |
|---|---|---|
| Empatica S.r.l. | 4 | 0 |
| Brain Sentinel, Inc. | 2 | 0 |
| EMPATICA SRL | 0 | 1 |
| Epiwatch, Inc. | 1 | 0 |
| Lgch, Inc. | 1 | 0 |
| Livassured BV | 1 | 0 |
| Neuro Event Labs OY | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 24, 2023 | EMPATICA SRL Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthcare facilities during periods of rest.
Models:
(1) Flamingo Pink EM2-FP-S;
(2) Open, Classified |
POS | K181861 |
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