The following data is part of a premarket notification filed by Canon U.s.a., Inc. with the FDA for Canon Autoref R-10.
Device ID | K841861 |
510k Number | K841861 |
Device Name: | CANON AUTOREF R-10 |
Classification | Refractometer, Ophthalmic |
Applicant | CANON U.S.A., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HKO |
CFR Regulation Number | 886.1760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-05-04 |
Decision Date | 1984-10-05 |