The following data is part of a premarket notification filed by Keeler Instruments, Inc. with the FDA for Oscar Colour Vision Tester.
Device ID | K832843 |
510k Number | K832843 |
Device Name: | OSCAR COLOUR VISION TESTER |
Classification | Tester, Color Vision |
Applicant | KEELER INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HIT |
CFR Regulation Number | 886.1170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-08-22 |
Decision Date | 1984-01-04 |