The following data is part of a premarket notification filed by American Optical Corp. with the FDA for Subjective Refractor, Mosel Sr-111.
Device ID | K771914 |
510k Number | K771914 |
Device Name: | SUBJECTIVE REFRACTOR, MOSEL SR-111 |
Classification | Refractometer, Ophthalmic |
Applicant | AMERICAN OPTICAL CORP. 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 | 1977-10-12 |
Decision Date | 1977-11-09 |