The following data is part of a premarket notification filed by Carl Zeiss, Inc. with the FDA for Humphrey Oct Scanner.
| Device ID | K961171 |
| 510k Number | K961171 |
| Device Name: | HUMPHREY OCT SCANNER |
| Classification | Ophthalmoscope, 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 | HLI |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-25 |
| Decision Date | 1996-06-21 |
| Summary: | summary |