IQQA Guide

System, X-ray, Tomography, Computed

EDDA TECHNOLOGY

The following data is part of a premarket notification filed by Edda Technology with the FDA for Iqqa Guide.

Pre-market Notification Details

Device IDK151414
510k NumberK151414
Device Name:IQQA Guide
ClassificationSystem, X-ray, Tomography, Computed
Applicant EDDA TECHNOLOGY 5 INDEPENDENCE WAY Princeton,  NJ  08540
ContactXiaolan Zeng
CorrespondentDaniel Kamm
EDDA TECHNOLOGY 5 INDEPENDENCE WAY Princeton,  NJ  08540
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-05-27
Decision Date2015-11-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00868466000237 K151414 000

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