FDA 510(k) Application Details - K161676

Device Classification Name	Spirometer, Diagnostic   More FDA Info for this Device
510(K) Number	K161676
Device Name	Spirometer, Diagnostic
Applicant	FIM MEDICAL 51 RUE PRIMAT CS 60194 Villeurbanne Cedex , Rhone 69625 FR Other 510(k) Applications for this Company
Contact	LIZA PERRAT 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	06/17/2016
Decision Date	10/20/2016
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