The following data is part of a premarket notification filed by Carl Zeiss Meditec Inc with the FDA for Cirrus Hd-oct, Model 4000.
| Device ID | K063378 |
| 510k Number | K063378 |
| Device Name: | CIRRUS HD-OCT, MODEL 4000 |
| Classification | Ophthalmoscope, Ac-powered |
| Applicant | CARL ZEISS MEDITEC INC 5160 HACIENDA DR. Dublin, CA 94568 |
| Contact | Judith A Brimacombe |
| Correspondent | Judith A Brimacombe CARL ZEISS MEDITEC INC 5160 HACIENDA DR. Dublin, CA 94568 |
| Product Code | HLI |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-08 |
| Decision Date | 2007-01-26 |
| Summary: | summary |