FDA 510(k) Application Details - K150810

Device Classification Name	Calculator, Pulmonary Function Data   More FDA Info for this Device
510(K) Number	K150810
Device Name	Calculator, Pulmonary Function Data
Applicant	CareFusion Germany 234 GmbH Leibnizstrasse 7 Hoechberg 97204 DE Other 510(k) Applications for this Company
Contact	Elmar Niedermeyer Other 510(k) Applications for this Contact
Regulation Number	868.1880   More FDA Info for this Regulation Number
Classification Product Code	BZC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/26/2015
Decision Date	08/14/2015
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