The following data is part of a premarket notification filed by Carl Zeiss Meditec Inc with the FDA for Cirrus Hd-oct.
| Device ID | K150977 |
| 510k Number | K150977 |
| Device Name: | CIRRUS HD-OCT |
| Classification | Tomography, Optical Coherence |
| Applicant | CARL ZEISS MEDITEC INC 5160 HACIENDA DR. Dublin, CA 94568 |
| Contact | Mandy Ambrecht |
| Correspondent | Mandy Ambrecht 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 | 2015-04-13 |
| Decision Date | 2015-09-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04057748087097 | K150977 | 000 |
| 04057748087080 | K150977 | 000 |