The following data is part of a premarket notification filed by Zeiss Humphrey System with the FDA for The Humphrey Field Analyzer Model 610.
Device ID | K821940 |
510k Number | K821940 |
Device Name: | THE HUMPHREY FIELD ANALYZER MODEL 610 |
Classification | Perimeter, Automatic, Ac-powered |
Applicant | ZEISS HUMPHREY SYSTEM 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | HPT |
CFR Regulation Number | 886.1605 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-06-29 |
Decision Date | 1982-07-28 |