HEIDELBERG RETINA TOMOGRAPH

Ophthalmoscope, Ac-powered

HEIDELBERG ENGINEERING

The following data is part of a premarket notification filed by Heidelberg Engineering with the FDA for Heidelberg Retina Tomograph.

Pre-market Notification Details

Device IDK912891
510k NumberK912891
Device Name:HEIDELBERG RETINA TOMOGRAPH
ClassificationOphthalmoscope, Ac-powered
Applicant HEIDELBERG ENGINEERING 5661 PALMER WAY, SUITE G Carlsbad,  CA  92008
ContactGerhard Zinser
CorrespondentGerhard Zinser
HEIDELBERG ENGINEERING 5661 PALMER WAY, SUITE G Carlsbad,  CA  92008
Product CodeHLI  
CFR Regulation Number886.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-07-01
Decision Date1991-09-27

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