The following data is part of a premarket notification filed by Techna Vision with the FDA for Techna Vision Auto-perimeter.
Device ID | K853290 |
510k Number | K853290 |
Device Name: | TECHNA VISION AUTO-PERIMETER |
Classification | Perimeter, Automatic, Ac-powered |
Applicant | TECHNA VISION 11489 WOODSIDE AVE. Santee, CA 92071 |
Contact | James Terry |
Correspondent | James Terry TECHNA VISION 11489 WOODSIDE AVE. Santee, CA 92071 |
Product Code | HPT |
CFR Regulation Number | 886.1605 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-08-05 |
Decision Date | 1985-11-12 |