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 |