FDA 510(k) Application Details - K161295

Device Classification Name	Calculator, Pulmonary Function Data   More FDA Info for this Device
510(K) Number	K161295
Device Name	Calculator, Pulmonary Function Data
Applicant	PULMONE ADVANCED MEDICAL DEVICES, LTD 14 HACHAROSHET ST RaÆananna 4365707 IL Other 510(k) Applications for this Company
Contact	Avi Lazar 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	05/09/2016
Decision Date	10/21/2016
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