Spectralis HRA+OCT And Variants With High Magnification Module

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 With High Magnification Module.

Pre-market Notification Details

Device IDK182569
510k NumberK182569
Device Name:Spectralis HRA+OCT And Variants With High Magnification Module
ClassificationTomography, Optical Coherence
Applicant Heidelberg Engineering GmbH Max-Jarecki-Strasse 8 Heidelberg,  DE 69115
ContactArianna Schoess
CorrespondentLena Sattler
Orasi Consulting, LLC. 1655 Forest Dr. Medina,  OH  44256
Product CodeOBO  
CFR Regulation Number886.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-09-18
Decision Date2018-10-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04059237000211 K182569 000
04059237000594 K182569 000
04059237000570 K182569 000

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