Demetra Dermatoscope BDEM-01
K-Number: K213957 · 2022-03-11
ApplicantBarco N.V.
Decision Date2022-03-11
Product CodePSN
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Demetra Dermatoscope BDEM-01 is a medical device manufactured by Barco N.V.. It received FDA 510(k) clearance on 2022-03-11 under approval number K213957. The device is classified under product code PSN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Demetra Dermatoscope BDEM-01?
Demetra Dermatoscope BDEM-01 is a medical device that received FDA 510(k) clearance on 2022-03-11. It is manufactured by Barco N.V.. The 510(k) number is K213957.
When was Demetra Dermatoscope BDEM-01 approved by the FDA?
Demetra Dermatoscope BDEM-01 received FDA 510(k) clearance on 2022-03-11, under approval number K213957.
What company makes Demetra Dermatoscope BDEM-01?
Demetra Dermatoscope BDEM-01 is manufactured by Barco N.V..
What is the FDA product code for Demetra Dermatoscope BDEM-01?
The FDA product code for Demetra Dermatoscope BDEM-01 is PSN.
Other Devices by Barco N.V.
Related Devices (Code: PSN)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.