SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM)

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 Anterior Segment Module (spectralis Asm).

Pre-market Notification Details

Device IDK113129
510k NumberK113129
Device Name:SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM)
ClassificationTomography, Optical Coherence
Applicant HEIDELBERG ENGINEERING GMBH TIERGARTENSTRASSE 15 Heidelberg,  DE 69121
ContactGerhard Zinser
Product CodeOBO  
CFR Regulation Number886.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2011-10-24
Decision Date2011-11-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04059237000112 K113129 000

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