FDA 510(k) Application Details - K111764

Device Classification Name	Spirometer, Diagnostic   More FDA Info for this Device
510(K) Number	K111764
Device Name	Spirometer, Diagnostic
Applicant	PULMONX, INC. 700 CHESAPEAKE DRIVE REDWOOD CITY, CA 94063 US Other 510(k) Applications for this Company
Contact	HANS SCHULZ 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	06/23/2011
Decision Date	11/10/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review