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Demetra BDEM-01 Dermatoscope

by Barco N.V. United States 510(k)

510(k) K192829 Product code PSN

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK192829 Date13 Dec 2019ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
PSN
Device Class
Class II
Regulation
21 CFR Part 878.4580
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Other devices from Barco N.V.

See all devices from Barco N.V. →

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K192829 24 fields · synced 22 Oct 2026