The following data is part of a premarket notification filed by Canon U.s.a., Inc. with the FDA for Canon Autorefractometer R-22.
| Device ID | K883200 |
| 510k Number | K883200 |
| Device Name: | CANON AUTOREFRACTOMETER R-22 |
| Classification | Refractometer, Ophthalmic |
| Applicant | CANON U.S.A., INC. ONE JERICHO PLAZA Jericho, NY 11753 -1000 |
| Contact | Tamada |
| Correspondent | Tamada CANON U.S.A., INC. ONE JERICHO PLAZA Jericho, NY 11753 -1000 |
| Product Code | HKO |
| CFR Regulation Number | 886.1760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-28 |
| Decision Date | 1988-08-18 |