The following data is part of a premarket notification filed by Gimmi Gmbh with the FDA for Alphaxenon Light 180 W And 300 W.
| Device ID | K093125 |
| 510k Number | K093125 |
| Device Name: | ALPHAXENON LIGHT 180 W AND 300 W |
| Classification | Light Source, Endoscope, Xenon Arc |
| Applicant | GIMMI GMBH CARL-ZEISS-STRASSE 6 Tuttlingen, DE D-78532 |
| Contact | Ulrich Henzler |
| Correspondent | Ulrich Henzler GIMMI GMBH CARL-ZEISS-STRASSE 6 Tuttlingen, DE D-78532 |
| Product Code | GCT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-02 |
| Decision Date | 2010-01-27 |
| Summary: | summary |