FDA 510(k) Application Details - K040549

Device Classification Name	Calculator, Predicted Values, Pulmonary Function   More FDA Info for this Device
510(K) Number	K040549
Device Name	Calculator, Predicted Values, Pulmonary Function
Applicant	COSMED S.R.L. 1129 BLOOMFIELD AVE. WEST CALDWELL, NJ 07006 US Other 510(k) Applications for this Company
Contact	ROBERT SCHIFF 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	03/02/2004
Decision Date	09/28/2004
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