The following data is part of a premarket notification filed by Berchtold Holding Gmbh with the FDA for Chromophare X 65.
| Device ID | K024132 |
| 510k Number | K024132 |
| Device Name: | CHROMOPHARE X 65 |
| Classification | Light, Surgical, Ceiling Mounted |
| Applicant | BERCHTOLD HOLDING GMBH LUDWIGSTALER STR. 25 Tuttlingen, DE D-78532 |
| Contact | Jorg Schneider |
| Correspondent | Jorg Schneider BERCHTOLD HOLDING GMBH LUDWIGSTALER STR. 25 Tuttlingen, DE D-78532 |
| Product Code | FSY |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-16 |
| Decision Date | 2003-03-21 |
| Summary: | summary |