FDA 510(k) Application Details - K081693

Device Classification Name	Meter, Airway Pressure (Inspiratory Force)   More FDA Info for this Device
510(K) Number	K081693
Device Name	Meter, Airway Pressure (Inspiratory Force)
Applicant	INSTRUMENTATION INDUSTRIES, INC. 2990 INDUSTRIAL BLVD. BETHEL PARK, PA 15102 US Other 510(k) Applications for this Company
Contact	DORIS F WALTER Other 510(k) Applications for this Contact
Regulation Number	868.1780   More FDA Info for this Regulation Number
Classification Product Code	BXR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/17/2008
Decision Date	09/11/2008
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