FDA 510(k) Application Details - K093174

Device Classification Name	Spirometer, Diagnostic   More FDA Info for this Device
510(K) Number	K093174
Device Name	Spirometer, Diagnostic
Applicant	COSMED S.R.L. 1129 BLOOMFIELD AVENUE SUITE 202 WEST CALDWELL, NJ 07006 US Other 510(k) Applications for this Company
Contact	ROBERT SCHIFF Other 510(k) Applications for this Contact
Regulation Number	868.1840   More FDA Info for this Regulation Number
Classification Product Code	BZG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/08/2009
Decision Date	02/26/2010
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