Demetra BDEM-01 Dermatoscope
K-Number: K192829 · 2019-12-13
ApplicantBarco N.V.
Decision Date2019-12-13
Product CodePSN
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Demetra BDEM-01 Dermatoscope is a medical device manufactured by Barco N.V.. It received FDA 510(k) clearance on 2019-12-13 under approval number K192829. 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 BDEM-01 Dermatoscope?
Demetra BDEM-01 Dermatoscope is a medical device that received FDA 510(k) clearance on 2019-12-13. It is manufactured by Barco N.V.. The 510(k) number is K192829.
When was Demetra BDEM-01 Dermatoscope approved by the FDA?
Demetra BDEM-01 Dermatoscope received FDA 510(k) clearance on 2019-12-13, under approval number K192829.
What company makes Demetra BDEM-01 Dermatoscope?
Demetra BDEM-01 Dermatoscope is manufactured by Barco N.V..
What is the FDA product code for Demetra BDEM-01 Dermatoscope?
The FDA product code for Demetra BDEM-01 Dermatoscope 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.