The following data is part of a premarket notification filed by Carl Zeiss, Inc. with the FDA for Zeiss Confocal Laser Scanning Ophthalmoscope(clso).
| Device ID | K912581 |
| 510k Number | K912581 |
| Device Name: | ZEISS CONFOCAL LASER SCANNING OPHTHALMOSCOPE(CLSO) |
| Classification | Ophthalmoscope, Ac-powered |
| Applicant | CARL ZEISS, INC. 305 COLLEGE RD. EAST Princeton, NJ 08540 |
| Contact | Christopher Talbot |
| Correspondent | Christopher Talbot CARL ZEISS, INC. 305 COLLEGE RD. EAST Princeton, NJ 08540 |
| Product Code | HLI |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-12 |
| Decision Date | 1991-12-23 |