FDA 510(k) Application Details - K192174

Device Classification Name	More FDA Info for this Device
510(K) Number	K192174
Device Name	SPY Portable Handheld Imaging (SPY-PHI) System
Applicant	Novadaq Technologies ULC. (now a part of Stryker) 8329 Eastlake Drive, Unit 101 Burnaby V5A 4W2 CA Other 510(k) Applications for this Company
Contact	Agatha Szeliga Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/12/2019
Decision Date	11/15/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review