FDA 510(k) Application Details - K070490

Device Classification Name	Spirometer, Therapeutic (Incentive)   More FDA Info for this Device
510(K) Number	K070490
Device Name	Spirometer, Therapeutic (Incentive)
Applicant	ADVANCED CIRCULATORY SYSTEMS, INC. 3460 POINTE CREEK CT. #102 BONITA SPRINGS, FL 34134-2015 US Other 510(k) Applications for this Company
Contact	PAUL DRYDEN Other 510(k) Applications for this Contact
Regulation Number	868.5690   More FDA Info for this Regulation Number
Classification Product Code	BWF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/20/2007
Decision Date	06/20/2007
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