FDA 510(k) Application Details - K090722

Device Classification Name	Calculator, Predicted Values, Pulmonary Function   More FDA Info for this Device
510(K) Number	K090722
Device Name	Calculator, Predicted Values, Pulmonary Function
Applicant	SHAPE MEDICAL SYSTEMS, INC 1313 5TH AVE. SE SUITE 205 MINNEAPOLIS, MN 55414 US Other 510(k) Applications for this Company
Contact	CLARENCE JOHNSON Other 510(k) Applications for this Contact
Regulation Number	868.1890   More FDA Info for this Regulation Number
Classification Product Code	BTY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/19/2009
Decision Date	03/31/2009
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	Y
Expedited Review