The following data is part of a De Novo classification by Sensimed Ag with the FDA for Sensimed Triggerfish.
| DeNovo ID | DEN140017 |
| Device Name: | SENSIMED TRIGGERFISH |
| Classification | Ocular Pattern Recorder |
| Applicant | SENSIMED AG 16 Appleton Street Waltham, MA 02453 |
| Contact | Marcy Moore |
| Product Code | PLZ |
| CFR Regulation Number | 886.1925 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Ophthalmic |
| Classification Advisory | Ophthalmic |
| Type | Direct |
| Date Received | 2014-05-06 |
| Decision Date | 2016-03-04 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640153470157 | DEN140017 | 000 |
| 07640153470027 | DEN140017 | 000 |
| 07640153470034 | DEN140017 | 000 |
| 07640153470041 | DEN140017 | 000 |
| 07640153470058 | DEN140017 | 000 |
| 07640153470065 | DEN140017 | 000 |
| 07640153470072 | DEN140017 | 000 |
| 07640153470089 | DEN140017 | 000 |
| 07640153470096 | DEN140017 | 000 |
| 07640153470102 | DEN140017 | 000 |
| 07640153470119 | DEN140017 | 000 |
| 07640153470126 | DEN140017 | 000 |
| 07640153470133 | DEN140017 | 000 |
| 07640153470140 | DEN140017 | 000 |
| 07640153470010 | DEN140017 | 000 |