FDA 510(k) Application Details - K143148

Device Classification Name	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)   More FDA Info for this Device
510(K) Number	K143148
Device Name	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Applicant	Westmed, Inc. 5580 S. Nogales Hwy. Tucson, AZ 85706 US Other 510(k) Applications for this Company
Contact	DIANA UPP Other 510(k) Applications for this Contact
Regulation Number	868.2600   More FDA Info for this Regulation Number
Classification Product Code	CAP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/03/2014
Decision Date	08/11/2015
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