510(k) K213957
K213957 is an FDA 510(k) premarket notification submitted by Barco N.V. for the device "Demetra Dermatoscope BDEM-01". The FDA issued a decision of Substantially Equivalent on March 11, 2022. The device falls under product code PSN (Light Based Imaging), a Class II device regulated under 21 CFR 878.4580. Barco N.V. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 11, 2022
- Date Received
- December 17, 2021
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light Based Imaging
- Device Class
- Class II
- Regulation Number
- 878.4580
- Review Panel
- SU
- Submission Type
Emission and collection of light to create an image for medical purposes