The following data is part of a premarket notification filed by Heidelberg Engineering with the FDA for Heidelberg Retina Tomograph.
| Device ID | K912891 |
| 510k Number | K912891 |
| Device Name: | HEIDELBERG RETINA TOMOGRAPH |
| Classification | Ophthalmoscope, Ac-powered |
| Applicant | HEIDELBERG ENGINEERING 5661 PALMER WAY, SUITE G Carlsbad, CA 92008 |
| Contact | Gerhard Zinser |
| Correspondent | Gerhard Zinser HEIDELBERG ENGINEERING 5661 PALMER WAY, SUITE G Carlsbad, CA 92008 |
| Product Code | HLI |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-01 |
| Decision Date | 1991-09-27 |