SEM Scanner (Model 200)
FDA 510(k) clearance DEN170021 · decided 2018-12-20
Clearance details
- K-number
- DEN170021
- Device name
- SEM Scanner (Model 200)
- Applicant
- Bruin Biometrics, LLC
- Decision
- Unknown
- Date received
- 2017-04-03
- Decision date
- 2018-12-20
- Days to decision
- 626 days
- Clearance type
- Direct
- Product code
- QEF
- Device class
- 1
- Regulation number
- 876.2100
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Los Angeles, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Bruin Biometrics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Recalls involving this device
No recalls on record reference this clearance.