SPY Elite Intraoperative Perfusion Assessment System

System, X-ray, Angiographic

Novadaq Technologies ULC. (now A Part Of Stryker)

The following data is part of a premarket notification filed by Novadaq Technologies Ulc. (now A Part Of Stryker) with the FDA for Spy Elite Intraoperative Perfusion Assessment System.

Pre-market Notification Details

Device IDK182907
510k NumberK182907
Device Name:SPY Elite Intraoperative Perfusion Assessment System
ClassificationSystem, X-ray, Angiographic
Applicant Novadaq Technologies ULC. (now A Part Of Stryker) 8329 Eastlake Drive, Unit 101 Burnaby,  CA V5a 4w2
ContactAgatha Szeliga
CorrespondentAgatha Szeliga
Novadaq Technologies ULC. (now A Part Of Stryker) 8329 Eastlake Drive, Unit 101 Burnaby,  CA V5a 4w2
Product CodeIZI  
CFR Regulation Number892.1600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2018-10-17
Decision Date2019-01-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20858701006265 K182907 000

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