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 |