The following data is part of a premarket notification filed by American Optical Corp. with the FDA for Sr-iv Programmed Subjective Refractor.
| Device ID | K802183 |
| 510k Number | K802183 |
| Device Name: | SR-IV PROGRAMMED SUBJECTIVE REFRACTOR |
| 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 | 1980-09-09 |
| Decision Date | 1981-04-23 |