The following data is part of a premarket notification filed by Applied Vision Concepts, Inc. with the FDA for Occu-tech Vision Test.
Device ID | K881971 |
510k Number | K881971 |
Device Name: | OCCU-TECH VISION TEST |
Classification | Chart, Visual Acuity |
Applicant | APPLIED VISION CONCEPTS, INC. 9898 SW LYNNWOOD TERR. Portland, OR 97225 |
Contact | Salibello, Od |
Correspondent | Salibello, Od APPLIED VISION CONCEPTS, INC. 9898 SW LYNNWOOD TERR. Portland, OR 97225 |
Product Code | HOX |
CFR Regulation Number | 886.1150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-05-11 |
Decision Date | 1988-11-25 |