FDA 510(k) Application Details - K180510

Device Classification Name	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)   More FDA Info for this Device
510(K) Number	K180510
Device Name	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Applicant	Instrumentation Industries, Inc. 2990 Industrial Blvd. Bethel Park, PA 15102 US Other 510(k) Applications for this Company
Contact	Doris Walter 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	02/27/2018
Decision Date	05/01/2019
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