RETINA ANGIOGRAPH

Ophthalmoscope, Ac-powered

HEIDELBERG ENGINEERING

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

Pre-market Notification Details

Device IDK944261
510k NumberK944261
Device Name:RETINA ANGIOGRAPH
ClassificationOphthalmoscope, Ac-powered
Applicant HEIDELBERG ENGINEERING OPTISCHE MEB SYSTEME GMBH IM NEUENHEIMER FELD 519 D06900 Heidelberg,germany,  DE
ContactGerhard Zinser
CorrespondentGerhard Zinser
HEIDELBERG ENGINEERING OPTISCHE MEB SYSTEME GMBH IM NEUENHEIMER FELD 519 D06900 Heidelberg,germany,  DE
Product CodeHLI  
CFR Regulation Number886.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-09-01
Decision Date1994-11-14

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