FDA 510(k) Application Details - K182907

Device Classification Name	System, X-Ray, Angiographic   More FDA Info for this Device
510(K) Number	K182907
Device Name	System, X-Ray, Angiographic
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	892.1600   More FDA Info for this Regulation Number
Classification Product Code	IZI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/17/2018
Decision Date	01/23/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review