The following data is part of a premarket notification filed by Good-lite Co. with the FDA for Dot Visual Acvity Test 2000.
Device ID | K833956 |
510k Number | K833956 |
Device Name: | DOT VISUAL ACVITY TEST 2000 |
Classification | Chart, Visual Acuity |
Applicant | GOOD-LITE CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HOX |
CFR Regulation Number | 886.1150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-11-16 |
Decision Date | 1984-01-04 |