Demetra BDEM-01 Dermatoscope— 510(k) K192829
Substantially EquivalentBarco N.V.
FDA 510(k) clearance K192829 for Demetra BDEM-01 Dermatoscope, Substantially Equivalent on 2019-12-13. Applicant: Barco N.V.. Device class: 2.
Clearance details
- Applicant
- Barco N.V.
- Product code
- Code PSN
- Device class
- Class 2
- Regulation
- 21 CFR 878.4580
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kortrijk, BE
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