The following data is part of a premarket notification filed by Zeiss Humphrey System with the FDA for Humphrey Field Analyzer Model 630.
Device ID | K852639 |
510k Number | K852639 |
Device Name: | HUMPHREY FIELD ANALYZER MODEL 630 |
Classification | Perimeter, Automatic, Ac-powered |
Applicant | ZEISS HUMPHREY SYSTEM 2992 ALVARADO ST. P.O. BOX 5400 San Leandro, CA 94577 |
Contact | Dean A Knight |
Correspondent | Dean A Knight ZEISS HUMPHREY SYSTEM 2992 ALVARADO ST. P.O. BOX 5400 San Leandro, CA 94577 |
Product Code | HPT |
CFR Regulation Number | 886.1605 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-06-20 |
Decision Date | 1985-09-18 |