510(k) DEN170021
DEN170021 is an FDA 510(k) premarket notification submitted by Bruin Biometrics, LLC for the device "SEM Scanner (Model 200)". The FDA issued a decision of De Novo Granted on December 20, 2018. The device falls under product code QEF (Pressure Ulcer Management Tool), a Class I device regulated under 21 CFR 876.2100.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- December 20, 2018
- Date Received
- April 3, 2017
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pressure Ulcer Management Tool
- Device Class
- Class I
- Regulation Number
- 876.2100
- Review Panel
- GU
- Submission Type
A pressure ulcer management tool is a prescription device intended for patients at risk of developing pressure ulcers. The device provides output that supports a users decision to increase intervention. The device is an adjunct tool for pressure ulcer management that is not intended for detection or diagnostic purposes.