The following data is part of a premarket notification filed by Carl Zeiss Meditec, Inc. with the FDA for Cirrus Hd-oct.
| Device ID | K181534 |
| 510k Number | K181534 |
| Device Name: | CIRRUS HD-OCT |
| Classification | Tomography, Optical Coherence |
| Applicant | Carl Zeiss Meditec, Inc. 5160 Hacienda Drive Dublin, CA 94568 |
| Contact | Mandy Ambrecht |
| Correspondent | Mandy Ambrecht Carl Zeiss Meditec, Inc. 5160 Hacienda Drive Dublin, CA 94568 |
| Product Code | OBO |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-11 |
| Decision Date | 2019-02-15 |
| Summary: | summary |