Spectralis HRA+OCT And Variants

Tomography, Optical Coherence

Heidelberg Engineering GmbH

The following data is part of a premarket notification filed by Heidelberg Engineering Gmbh with the FDA for Spectralis Hra+oct And Variants.

Pre-market Notification Details

Device IDK201252
510k NumberK201252
Device Name:Spectralis HRA+OCT And Variants
ClassificationTomography, Optical Coherence
Applicant Heidelberg Engineering GmbH Max-Jarecki-Strasse 8 Heidelberg,  DE 69115
ContactChristoph Schoess
CorrespondentLena Sattler
Orasi Consulting, LLC. 1655 Forest Drive Medina,  OH  44256
Product CodeOBO  
CFR Regulation Number886.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-11
Decision Date2020-09-09

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