FDA 510(k) Application Details - K120635

Device Classification Name	Calculator, Predicted Values, Pulmonary Function   More FDA Info for this Device
510(K) Number	K120635
Device Name	Calculator, Predicted Values, Pulmonary Function
Applicant	NDD MEDIZITECHNIK AG TWO DUNDEE PARK ANDOVER, MA 01810 US Other 510(k) Applications for this Company
Contact	GERARD MASIELLO 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	03/01/2012
Decision Date	09/27/2012
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