The following data is part of a premarket notification filed by Carl Zeiss, Inc. with the FDA for Opmi Cs.
| Device ID | K883581 |
| 510k Number | K883581 |
| Device Name: | OPMI CS |
| Classification | Microscope, Surgical |
| Applicant | CARL ZEISS, INC. ONE ZEISS DR. Thornwood, NY 10594 |
| Contact | Van Cader |
| Correspondent | Van Cader CARL ZEISS, INC. ONE ZEISS DR. Thornwood, NY 10594 |
| Product Code | EPT |
| CFR Regulation Number | 878.4700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-22 |
| Decision Date | 1988-09-13 |