FDA 510(k) Application Details - K061495

Device Classification Name	Lung Sound Monitor   More FDA Info for this Device
510(K) Number	K061495
Device Name	Lung Sound Monitor
Applicant	DEEP BREEZE LTD. 2001 PENNSYLVANIA AVENUE NW SUITE 575 WASHINGTON, DC 20006 US Other 510(k) Applications for this Company
Contact	PHILIP J PHILLIPS Other 510(k) Applications for this Contact
Regulation Number	870.1875   More FDA Info for this Regulation Number
Classification Product Code	OCR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/31/2006
Decision Date	07/18/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review