SPY-PHI System With SPY-PHI Fluorescence Assessment Software

Confocal Optical Imaging

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-phi System With Spy-phi Fluorescence Assessment Software.

Pre-market Notification Details

Device IDK202244
510k NumberK202244
Device Name:SPY-PHI System With SPY-PHI Fluorescence Assessment Software
ClassificationConfocal Optical Imaging
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 CodeOWN  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2020-08-10
Decision Date2020-11-05

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