FDA 510(k) Application Details - K120118

Device Classification Name	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)   More FDA Info for this Device
510(K) Number	K120118
Device Name	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Applicant	VENTLAB CORP. 155 BOYCE DRIVE MOCKSVILLE, NC 27028 US Other 510(k) Applications for this Company
Contact	JAMES A COCHIE 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	01/17/2012
Decision Date	05/24/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review