The following data is part of a premarket notification filed by Canon U.s.a., Inc. with the FDA for Comprehensive Phoropter, Mdr-680.
| Device ID | K936205 |
| 510k Number | K936205 |
| Device Name: | COMPREHENSIVE PHOROPTER, MDR-680 |
| Classification | Refractor, Manual, Non-powered, Including Phoropter |
| Applicant | CANON U.S.A., INC. ONE CANON PLAZA Lake Success, NY 11042 -1198 |
| Contact | Koichi Yano |
| Correspondent | Koichi Yano CANON U.S.A., INC. ONE CANON PLAZA Lake Success, NY 11042 -1198 |
| Product Code | HKN |
| CFR Regulation Number | 886.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-29 |
| Decision Date | 1994-09-28 |