Company ยท US
Epitel, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2021 to 2025. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 21, 2025 | K243185 | REMI Remote EEG Monitoring System Epitel | OMC |
| Oct 17, 2024 | K240408 | REMI-AI Rapid Detection Module (REMI-AI RDM) Epitel, Inc. | OMB |
| Jan 3, 2024 | K231779 | REMI AI Discrete Detection Module Epitel, Inc. | OMB |
| Jun 30, 2023 | K230933 | REMI Remote EEG Monitoring System Epitel, Inc. | OMC |
| Mar 29, 2021 | K203827 | REMI Epitel, Inc. | OMC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||