FDA 510(k) Application Details - K161536

Device Classification Name	Spirometer, Diagnostic   More FDA Info for this Device
510(K) Number	K161536
Device Name	Spirometer, Diagnostic
Applicant	NDD MEDIZINTECHNIK AG TECHNOPARKSTRASSE 1 ZURICH 8005 CH 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	06/03/2016
Decision Date	01/05/2017
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