FDA Product Code
FDA Product Code QEF — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.2100
510(k) Clearances — 1 record
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| DEN170021 | SEM Scanner (Model 200) | Bruin Biometrics, LLC | 2018-12-20 | Direct | — |
Product code QEF · Class I · Gastroenterology, Urology. Data: openFDA.