FDA 510(k) Application Details - K183108

Device Classification Name	Spirometer, Therapeutic (Incentive)   More FDA Info for this Device
510(K) Number	K183108
Device Name	Spirometer, Therapeutic (Incentive)
Applicant	Trudell Medical International 725 Baransway Drive London n5V 5G4 CA Other 510(k) Applications for this Company
Contact	Marianne Tanton Other 510(k) Applications for this Contact
Regulation Number	868.5690   More FDA Info for this Regulation Number
Classification Product Code	BWF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/08/2018
Decision Date	08/16/2019
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