The following data is part of a premarket notification filed by Carlzeiss Meditec Inc. with the FDA for Nerve Fiber Analyzer.
| Device ID | K941705 |
| 510k Number | K941705 |
| Device Name: | NERVE FIBER ANALYZER |
| Classification | Ophthalmoscope, Ac-powered |
| Applicant | CARLZEISS MEDITEC INC. 9550 WAPLES STREET,STE 105 San Diego, CA 92121 |
| Contact | Andreas W Dreher |
| Correspondent | Andreas W Dreher CARLZEISS MEDITEC INC. 9550 WAPLES STREET,STE 105 San Diego, CA 92121 |
| Product Code | HLI |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-06 |
| Decision Date | 1994-07-18 |