| DeNovo ID | DEN170056 |
| Device Name: | Parathyroid Detection (Model PTeye) System |
| Classification | Parathyroid Autofluorescence Detection Device |
| Applicant | AiBiomed, Corp. 107 West Gutierrez Sreet Santa Barbara, CA 93101 |
| Contact | Al Memmolo |
| Product Code | QDF |
| 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 | 2017-09-25 |
| Decision Date | 2018-11-02 |
| Reclassification Order: | Reclassification Order |