FDA 510(k) Application Details - K103530

Device Classification Name	Spirometer, Diagnostic   More FDA Info for this Device
510(K) Number	K103530
Device Name	Spirometer, Diagnostic
Applicant	MEDICAL INTERNATIONAL RESEARCH USA, INC. 1900 PEWAUKEE ROAD SUITE O WAUKESHA, WI 53188 US Other 510(k) Applications for this Company
Contact	ED KOHERE 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	12/01/2010
Decision Date	11/21/2011
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