FDA 510(k) Application Details - K053149

Device Classification Name	Spirometer, Therapeutic (Incentive)   More FDA Info for this Device
510(K) Number	K053149
Device Name	Spirometer, Therapeutic (Incentive)
Applicant	LEVENTON, S.A. C/NEWTON 18-24, POLIGONO INDUSTRIAL SESROVIRES, SANT ESTEVE SESROVIRES, BARCELONA 08635 ES Other 510(k) Applications for this Company
Contact	ORIOL VERNIS 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	11/10/2005
Decision Date	12/13/2005
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