The following data is part of a premarket notification filed by American Optical Corp. with the FDA for Sr-1v Data Printer.
Device ID | K812063 |
510k Number | K812063 |
Device Name: | SR-1V DATA PRINTER |
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 | 1981-07-21 |
Decision Date | 1981-08-18 |