FDA 510(k) Application Details - K153733

Device Classification Name	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)   More FDA Info for this Device
510(K) Number	K153733
Device Name	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Applicant	VORTRAN MEDICAL TECHNOLOGY 1, INC. 21 GOLDENLAND COURT, #100 SACRAMENTO, CA 95834 US Other 510(k) Applications for this Company
Contact	JAMES LEE 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	12/28/2015
Decision Date	09/16/2016
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