The following data is part of a premarket notification filed by Titmus Optical, Inc. with the FDA for Titmus Vision Tester Ii.
Device ID | K844694 |
510k Number | K844694 |
Device Name: | TITMUS VISION TESTER II |
Classification | Tester, Color Vision |
Applicant | TITMUS OPTICAL, INC. Petersburg, VA 23803 |
Contact | Kinsey |
Correspondent | Kinsey TITMUS OPTICAL, INC. Petersburg, VA 23803 |
Product Code | HIT |
CFR Regulation Number | 886.1170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-12-03 |
Decision Date | 1985-01-22 |