The following data is part of a premarket notification filed by Heidelberg Engineering with the FDA for Heidelberg Retina Angiograph 2/optical Coherence Tomograph, Model Hra 2/oct.
| Device ID | K063191 |
| 510k Number | K063191 |
| Device Name: | HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODEL HRA 2/OCT |
| Classification | Tomography, Optical Coherence |
| Applicant | HEIDELBERG ENGINEERING TIERGARTENSTRASSE 15 Heidelberg, DE 69121 |
| Contact | Gerhard Zinser |
| Product Code | OBO |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-10-20 |
| Decision Date | 2006-10-31 |
| Summary: | summary |