SPY FLUORESCENT IMAGING SYSTEM

System, X-ray, Angiographic

NOVADAQ TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Novadaq Technologies, Inc. with the FDA for Spy Fluorescent Imaging System.

Pre-market Notification Details

Device IDK073130
510k NumberK073130
Device Name:SPY FLUORESCENT IMAGING SYSTEM
ClassificationSystem, X-ray, Angiographic
Applicant NOVADAQ TECHNOLOGIES, INC. 2585 SKYMARK AVENUE, STE. 306 Mississauga, Ontario,  CA L4w 4l5
ContactAllison Manners
CorrespondentAllison Manners
NOVADAQ TECHNOLOGIES, INC. 2585 SKYMARK AVENUE, STE. 306 Mississauga, Ontario,  CA L4w 4l5
Product CodeIZI  
CFR Regulation Number892.1600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-11-06
Decision Date2008-01-10
Summary:summary

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