The following data is part of a premarket notification filed by Carl Zeiss, Inc. with the FDA for Humphrey Field Analyzer (hfa Ii).
| Device ID | K954167 |
| 510k Number | K954167 |
| Device Name: | HUMPHREY FIELD ANALYZER (HFA II) |
| Classification | Perimeter, Automatic, Ac-powered |
| Applicant | CARL ZEISS, INC. ONE ZEISS DR. Thornwood, NY 10594 |
| Contact | Kenneth M Nicoll |
| Correspondent | Kenneth M Nicoll CARL ZEISS, INC. ONE ZEISS DR. Thornwood, NY 10594 |
| Product Code | HPT |
| CFR Regulation Number | 886.1605 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-05 |
| Decision Date | 1995-11-24 |