FDA 510(k) Application Details - K172388

Device Classification Name	Spirometer, Therapeutic (Incentive)   More FDA Info for this Device
510(K) Number	K172388
Device Name	Spirometer, Therapeutic (Incentive)
Applicant	Advanced Circulatory System, a wholly owned subsidiary of ZOLL 1905 County Rd C West Roseville, MN 55113 US Other 510(k) Applications for this Company
Contact	Anja Metzger 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	08/08/2017
Decision Date	12/22/2017
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