K936205 is an FDA 510(k) clearance for the COMPREHENSIVE PHOROPTER, MDR-680. This device is classified as a Refractor, Manual, Non-powered, Including Phoropter (Class I - General Controls, product code HKN).
Submitted by Canon USA, Inc. (Lake Success, US). The FDA issued a Cleared decision on September 28, 1994, 273 days after receiving the submission on December 29, 1993.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1770.
| 510(k) Number | K936205 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 1993 |
| Decision Date | September 28, 1994 |
| Days to Decision | 273 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | HKN — Refractor, Manual, Non-powered, Including Phoropter |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.1770 |