FDA 510(k) Application Details - K090034

Device Classification Name	Spirometer, Diagnostic   More FDA Info for this Device
510(K) Number	K090034
Device Name	Spirometer, Diagnostic
Applicant	NDD MEDIZITECHNIK AG TWO DUNDEE PARK ANDOVER, MA 01810 US Other 510(k) Applications for this Company
Contact	JERRY MASIELLO 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	01/06/2009
Decision Date	06/02/2009
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