FDA 510(k) Application Details - K133428

Device Classification Name	Spirometer, Diagnostic   More FDA Info for this Device
510(K) Number	K133428
Device Name	Spirometer, Diagnostic
Applicant	MEDIKRO OY KELLOLAHDENTIE 27 KUOPIO FI-70460 FI Other 510(k) Applications for this Company
Contact	MIKKO ELORANTA 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	11/08/2013
Decision Date	05/21/2014
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