The following data is part of a De Novo classification by Rebiscan, Inc. with the FDA for Pediatric Vision Scanner.
| DeNovo ID | DEN130051 |
| Device Name: | PEDIATRIC VISION SCANNER |
| Classification | Strabismus Detection Device |
| Applicant | REBISCAN, INC. 30 Mount Auburn Street, Ste B Cambridge, MA 02138 |
| Contact | Justin G Shaka |
| Product Code | PMW |
| CFR Regulation Number | 886.1342 [🔎] |
| 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 | 2013-12-13 |
| Decision Date | 2016-06-08 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |