The following data is part of a premarket notification filed by Carl Zeiss Meditec Ag with the FDA for Blue 400.
| Device ID | K211346 |
| 510k Number | K211346 |
| Device Name: | BLUE 400 |
| Classification | Diagnostic Neurosurgical Microscope Filter |
| Applicant | Carl Zeiss Meditec AG Goeschwitzer Strasse 51-52 Jena, DE 07745 |
| Contact | Hans-Joachim Miesner |
| Correspondent | Maria Golovina Carl Zeiss Meditec Inc 5300 Central Parkway Dublin, CA 94568 |
| Product Code | QFX |
| CFR Regulation Number | 882.4950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-03 |
| Decision Date | 2022-07-22 |