Product areas
FDA product code distribution
Gme German Medical Engineering GmbH
Country / Region:United States (US)
510(k) submissions
4 total
Showing 1–4
| K number | Device name | Product code | Class | Decision |
|---|---|---|---|---|
| K221623 | FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm | GEX | Class 2 | 2023-03-10 |
| K203054 | FlexSys | GEX | Class 2 | 2021-03-05 |
| K192269 | TwinScan 808/755 Laser System | GEX | Class 2 | 2019-11-19 |
| K180518 | GME LinScan Lite 808 Laser System | GEX | Class 2 | 2018-07-23 |
Company profile
- Canonical name
- Gme German Medical Engineering GmbH
- Aliases
- Gme (German Medical Engineering) GmbH
- Country / Region
- United States(US)
Predicate manufacturers
Companies whose devices this company cited as predicates
2 manufacturers
- 2
- 1
Citing manufacturers
Companies that cited this company's devices as predicates
1 manufacturers
- 2