The following data is part of a premarket notification filed by Carl Zeiss Ophthalmic Systems, Inc. with the FDA for Humphrey Oct3.
| Device ID | K012727 |
| 510k Number | K012727 |
| Device Name: | HUMPHREY OCT3 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | CARL ZEISS OPHTHALMIC SYSTEMS, INC. 5160 HACIENDA DR. Dublin, CA 94568 |
| Contact | Melisssa R Horne |
| Correspondent | Melisssa R Horne CARL ZEISS OPHTHALMIC SYSTEMS, INC. 5160 HACIENDA DR. Dublin, CA 94568 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-15 |
| Decision Date | 2002-01-31 |
| Summary: | summary |