Product areas
FDA product code distribution
Gme German Medical Engineering GmbH
Country / region:United States (US)
510(k) submissions
4
Filtered: GEX
Latest clearance
2023-03-10
Product codes
1
GEX
510(k) submissions
4 total · filtered by GEX
| K number | Device name | Product code | Class | Decision date |
|---|---|---|---|---|
| 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
- United States(US)
Cited predicates
14- K130193
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Not ingested - K150752
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Not ingested - K171702
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Not ingested - K191086
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Not ingested - K203054
FlexSys
- K003142
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Not ingested - K031425
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Not ingested - K042474
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Not ingested - K053604
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Not ingested - K120460
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Not ingested - K133297
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Not ingested - K143519
The MeDioStar NeXT Family
- K180518
GME LinScan Lite 808 Laser System
- K141063
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Not ingested
Gme German Medical Engineering GmbH references 14 predicate/reference devices