SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FA

Tomography, Optical Coherence

HEIDELBERG ENGINEERING

The following data is part of a premarket notification filed by Heidelberg Engineering with the FDA for Spectralis Hra+oct, Spectralis Fa_oct, Spectralis Icga+ Oct, Spectralis Hra, Spectralis Fa.

Pre-market Notification Details

Device IDK101223
510k NumberK101223
Device Name:SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FA
ClassificationTomography, Optical Coherence
Applicant HEIDELBERG ENGINEERING 1220 NINETEENTH ST, NW SUITE 300 Washington,  DC  20036
ContactDiane Mandell-horwitz
CorrespondentDiane Mandell-horwitz
HEIDELBERG ENGINEERING 1220 NINETEENTH ST, NW SUITE 300 Washington,  DC  20036
Product CodeOBO  
CFR Regulation Number886.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-05-03
Decision Date2010-10-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04059237000280 K101223 000
04059237000075 K101223 000
04059237000051 K101223 000
04059237000044 K101223 000
04059237000037 K101223 000
04059237000020 K101223 000
04059237000013 K101223 000

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