Spectralis HRA + OCT And Variants (e.g.s Below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT Ith Multicolor

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 (e.g.s Below), Spectralis Fa+oct, Spectralis Icga+oct, Spectralis Oct Blue Peak, Spectralis Oct Ith Multicolor.

Pre-market Notification Details

Device IDK152205
510k NumberK152205
Device Name:Spectralis HRA + OCT And Variants (e.g.s Below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT Ith Multicolor
ClassificationTomography, Optical Coherence
Applicant Heidelberg Engineering GmbH Heidelberg,  DE 69121
ContactGerhard Zinser
CorrespondentDiane Horwitz
Mandell Horwitz Consultants LLC 2995 Steven Martin Dr. Fairfax,  VA  22031
Product CodeOBO  
CFR Regulation Number886.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-08-06
Decision Date2016-05-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04059237000358 K152205 000
04059237000341 K152205 000
04059237000310 K152205 000
04059237000303 K152205 000
04059237000259 K152205 000
04059237000150 K152205 000
04059237000136 K152205 000
04059237000105 K152205 000
04059237000068 K152205 000

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