The following data is part of a premarket notification filed by Zeiss Humphrey System with the FDA for Humphrey Image Analyzer Model 110.
| Device ID | K852638 |
| 510k Number | K852638 |
| Device Name: | HUMPHREY IMAGE ANALYZER MODEL 110 |
| Classification | Camera, Ophthalmic, 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 | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-20 |
| Decision Date | 1985-08-12 |