FDA 510(k) Application Details - K994074

Device Classification Name	Spirometer, Therapeutic (Incentive)   More FDA Info for this Device
510(K) Number	K994074
Device Name	Spirometer, Therapeutic (Incentive)
Applicant	LEVENTON, S.A. POLIGONO CAN SUYER, 11 SANT ANDREU DE LA BARCA BARCELONA 08740 ES Other 510(k) Applications for this Company
Contact	JOAQUIM SORIANO 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	12/02/1999
Decision Date	06/08/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review