The following data is part of a premarket notification filed by Carlzeiss Meditec Inc. with the FDA for Angioscan (as Stand Alone Instrument).
| Device ID | K951132 |
| 510k Number | K951132 |
| Device Name: | ANGIOSCAN (AS STAND ALONE INSTRUMENT) |
| 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 | 1995-03-13 |
| Decision Date | 1995-06-26 |