FDA 510(k) Application Details - K083199

Device Classification Name	Spirometer, Diagnostic   More FDA Info for this Device
510(K) Number	K083199
Device Name	Spirometer, Diagnostic
Applicant	PULMONX, INC. 1047 ELWELL COURT PALO ALTO, CA 94303 US Other 510(k) Applications for this Company
Contact	SUZON LOMMEL 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	10/30/2008
Decision Date	06/25/2009
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