The following data is part of a De Novo classification by Fluoptics with the FDA for Fluobeam 800 Clinic Imaging Device Used With Fluocase 800 Control System.
| DeNovo ID | DEN170092 |
| Device Name: | Fluobeam 800 Clinic Imaging Device Used With Fluocase 800 Control System |
| Classification | Parathyroid Autofluorescence Imaging Device |
| Applicant | Fluoptics 7 Parvis Louis Neel cs 20050 Grenoble Cedex 9, FR 38040 |
| Contact | Odelie Allard |
| Product Code | QDG |
| CFR Regulation Number | 878.4550 [🔎] |
| 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 | General & Plastic Surgery |
| Classification Advisory | General & Plastic Surgery |
| Type | Direct |
| Date Received | 2017-12-22 |
| Decision Date | 2018-11-02 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |