HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODEL HRA 2/OCT

Tomography, Optical Coherence

HEIDELBERG ENGINEERING

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.

Pre-market Notification Details

Device IDK063191
510k NumberK063191
Device Name:HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODEL HRA 2/OCT
ClassificationTomography, Optical Coherence
Applicant HEIDELBERG ENGINEERING TIERGARTENSTRASSE 15 Heidelberg,  DE 69121
ContactGerhard Zinser
Product CodeOBO  
CFR Regulation Number886.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2006-10-20
Decision Date2006-10-31
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.