The following data is part of a premarket notification filed by Carl Zeiss, Inc. with the FDA for Zeiss Voice Control System For Opmi's.
| Device ID | K860811 |
| 510k Number | K860811 |
| Device Name: | ZEISS VOICE CONTROL SYSTEM FOR OPMI'S |
| Classification | Microscope, Surgical |
| Applicant | CARL ZEISS, INC. ONE ZEISS DR. Thornwood, NY 10594 |
| Contact | Marie Pederson |
| Correspondent | Marie Pederson 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 | 1986-03-04 |
| Decision Date | 1986-04-30 |