K860811 is an FDA 510(k) clearance for the ZEISS VOICE CONTROL SYSTEM FOR OPMI'S. This device is classified as a Microscope, Surgical (Class I - General Controls, product code EPT).
Submitted by Carl Zeiss, Inc. (Thornwood, US). The FDA issued a Cleared decision on April 30, 1986, 57 days after receiving the submission on March 4, 1986.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4700.
| 510(k) Number | K860811 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 1986 |
| Decision Date | April 30, 1986 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | EPT — Microscope, Surgical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4700 |