FDA 510(k) Application Details - K181660

Device Classification Name	Spirometer, Therapeutic (Incentive)   More FDA Info for this Device
510(K) Number	K181660
Device Name	Spirometer, Therapeutic (Incentive)
Applicant	Smiths Medical 6000 Nathan Lane North Minneapolis, MN 55442 US Other 510(k) Applications for this Company
Contact	Donna Semlak 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	06/25/2018
Decision Date	10/24/2019
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