FDA 510(k) Application Details - K130322

Device Classification Name	Spirometer, Diagnostic   More FDA Info for this Device
510(K) Number	K130322
Device Name	Spirometer, Diagnostic
Applicant	BIONET CO., LTD. 5405 ALTON PARKWAY, SUITE A530 IRVINE, CA 92604 US Other 510(k) Applications for this Company
Contact	MARC GOODMAN 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	02/08/2013
Decision Date	11/15/2013
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