The following data is part of a premarket notification filed by Carl Zeiss, Inc. with the FDA for Zeiss Operating Keratometer.
| Device ID | K853723 |
| 510k Number | K853723 |
| Device Name: | ZEISS OPERATING KERATOMETER |
| Classification | Keratoscope, Ac-powered |
| Applicant | CARL ZEISS, INC. ONE ZEISS DR. Thornwood, NY 10594 |
| Contact | Jane Pederson |
| Correspondent | Jane Pederson CARL ZEISS, INC. ONE ZEISS DR. Thornwood, NY 10594 |
| Product Code | HLQ |
| CFR Regulation Number | 886.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-05 |
| Decision Date | 1985-10-15 |