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 IDK173648
510k NumberK173648
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 Dr. Medina,  OH  44256
Product CodeOBO  
CFR Regulation Number886.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-11-27
Decision Date2018-08-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04059237000549 K173648 000
04059237000525 K173648 000
04059237000501 K173648 000

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