Product areas
FDA product code distribution
Olympus Winter & Ibe GmbH
Country / Region:United States (US)
510(k) submissions
1
Latest clearance
2025-09-23
Product codes
1
GEI
Cited as predicate
0
510(k) submissions
1 total
Showing 1–1
| K number | Device name | Product code | Class | Decision |
|---|---|---|---|---|
| K252043 | Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211) | GEI | Class 2 | 2025-09-23 |
Company profile
- Canonical name
- Olympus Winter & Ibe GmbH
- Country / Region
- United States(US)
- Address
- Kuehnstrasse 61 Hamburg, DE 22045
Predicate manufacturers
Companies whose devices this company cited as predicates
No predicate manufacturers found
This company has not cited predicate devices with known manufacturers yet
Citing manufacturers
Companies that cited this company's devices as predicates
No citing manufacturers yet
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