FDA 510(k) Application Details - K170185

Device Classification Name	More FDA Info for this Device
510(K) Number	K170185
Device Name	tremoFlo C-100 Airwave Oscillometry System
Applicant	THORASYS Thoracic Medical Systems, Inc. 6560 Avenue de l'Esplanade Suite #103 Montreal H2v 4l5 CA Other 510(k) Applications for this Company
Contact	Sebastien Jutras Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/23/2017
Decision Date	09/12/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review