The following data is part of a premarket notification filed by Berchtold Holding Gmbh with the FDA for Chromophare.
| Device ID | K944855 |
| 510k Number | K944855 |
| Device Name: | CHROMOPHARE |
| Classification | Light, Surgical, Ceiling Mounted |
| Applicant | BERCHTOLD HOLDING GMBH POSTFACH 4052 Tuttlingen, DE D-78505 |
| Contact | W Hill |
| Correspondent | W Hill BERCHTOLD HOLDING GMBH POSTFACH 4052 Tuttlingen, DE D-78505 |
| Product Code | FSY |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-30 |
| Decision Date | 1994-10-19 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CHROMOPHARE 73351500 1292017 Live/Registered |
Gebruder Martin 1982-02-22 |
![]() CHROMOPHARE 73311128 1205348 Live/Registered |
Elmed Incorporated 1981-05-19 |