The following data is part of a premarket notification filed by Carl Zeiss Meditec Inc with the FDA for Cirrus Hd-oct With Retinal Nerve Fiber Layer And Macular Normative Databases, Model 4000.
| Device ID | K083291 |
| 510k Number | K083291 |
| Device Name: | CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER AND MACULAR NORMATIVE DATABASES, MODEL 4000 |
| Classification | Tomography, Optical Coherence |
| 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 | OBO |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-07 |
| Decision Date | 2009-05-05 |
| Summary: | summary |