The following data is part of a premarket notification filed by Heidelberg Engineering with the FDA for Heidelberg Retina Angiograph Fa/icga (hra/c).
| Device ID | K971671 |
| 510k Number | K971671 |
| Device Name: | HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C) |
| Classification | Ophthalmoscope, Ac-powered |
| Applicant | HEIDELBERG ENGINEERING TIERGARTENSTRASSE 17 Heidelberg, DE 69121 |
| Contact | Gerhard Zinser |
| Correspondent | Gerhard Zinser HEIDELBERG ENGINEERING TIERGARTENSTRASSE 17 Heidelberg, DE 69121 |
| Product Code | HLI |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-07 |
| Decision Date | 1997-07-29 |