FDA 510(k) Application Details - K192340

Device Classification Name	Transducer, Pressure, Catheter Tip   More FDA Info for this Device
510(K) Number	K192340
Device Name	Transducer, Pressure, Catheter Tip
Applicant	Opsens Inc 750 Boulevard du Parc Technologique Quebec GIP 4S3 CA Other 510(k) Applications for this Company
Contact	Marc Chaunet Other 510(k) Applications for this Contact
Regulation Number	870.2870   More FDA Info for this Regulation Number
Classification Product Code	DXO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/28/2019
Decision Date	12/12/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review