The following data is part of a De Novo classification by Bruin Biometrics, Llc with the FDA for Sem Scanner (model 200).
| DeNovo ID | DEN170021 |
| Device Name: | SEM Scanner (Model 200) |
| Classification | Pressure Ulcer Management Tool |
| Applicant | Bruin Biometrics, LLC 10960 Wilshire Blvd, Suite 950 Los Angeles, CA 90024 |
| Contact | Ya-chen Tonar |
| Product Code | QEF |
| CFR Regulation Number | 876.2100 [🔎] |
| 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 | Gastroenterology/Urology |
| Classification Advisory | Gastroenterology/Urology |
| Type | Direct |
| Date Received | 2017-04-03 |
| Decision Date | 2018-12-20 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860740002661 | DEN170021 | 000 |
| 00860740002654 | DEN170021 | 000 |
| 00860740002647 | DEN170021 | 000 |
| 10860740002637 | DEN170021 | 000 |
| 00860740002623 | DEN170021 | 000 |
| 00860740002616 | DEN170021 | 000 |