SPY INTRA-OPERATIVE IMAGING SYSTEM, MODEL SP2000

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 Intra-operative Imaging System, Model Sp2000.

Pre-market Notification Details

Device IDK071037
510k NumberK071037
Device Name:SPY INTRA-OPERATIVE IMAGING SYSTEM, MODEL SP2000
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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductYes
Date Received2007-04-12
Decision Date2007-05-10
Summary:summary

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