FDA 510(k) Application Details - K162131

Device Classification Name	Spirometer, Monitoring (W/Wo Alarm)   More FDA Info for this Device
510(K) Number	K162131
Device Name	Spirometer, Monitoring (W/Wo Alarm)
Applicant	Respiratory Motion Inc. 411 Waverly Oaks Road, Building 1, Suite 150 Waltham, MA 02452 US Other 510(k) Applications for this Company
Contact	Edwin Rule Other 510(k) Applications for this Contact
Regulation Number	868.1850   More FDA Info for this Regulation Number
Classification Product Code	BZK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/01/2016
Decision Date	05/09/2017
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