FDA 510(k) Application Details - K141793

Device Classification Name	Spirometer, Diagnostic   More FDA Info for this Device
510(K) Number	K141793
Device Name	Spirometer, Diagnostic
Applicant	PULMONE ADVANCED MEDICAL DEVICES, LTD. 200 PARK AVE, UNIT 403 MINNEAPOLIS, MN 55415 US Other 510(k) Applications for this Company
Contact	SUSAN ALPERT Other 510(k) Applications for this Contact
Regulation Number	868.1840   More FDA Info for this Regulation Number
Classification Product Code	BZG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/02/2014
Decision Date	03/06/2015
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