The following data is part of a premarket notification filed by Carl Zeiss Meditec Inc with the FDA for Guided Progression Analysis On The Humphrey Field Analyzer Ii And Ii -i Series.
| Device ID | K093213 |
| 510k Number | K093213 |
| Device Name: | GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIES |
| Classification | Perimeter, Automatic, Ac-powered |
| Applicant | CARL ZEISS MEDITEC INC 5160 HACIENDA DR. Dublin, CA 94568 |
| Contact | Judith A Brimacombe |
| Correspondent | Judith A Brimacombe CARL ZEISS MEDITEC INC 5160 HACIENDA DR. Dublin, CA 94568 |
| Product Code | HPT |
| CFR Regulation Number | 886.1605 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-13 |
| Decision Date | 2010-03-12 |
| Summary: | summary |