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FDA 510(k) Application Details - K073582
Device Classification Name
Lung Sound Monitor
More FDA Info for this Device
510(K) Number
K073582
Device Name
Lung Sound Monitor
Applicant
DEEP BREEZE LTD.
2001 PENNSYLVANIA AVENUE NW
SUITE 950
WASHINGTON, DC 20006 US
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Contact
JEFF BAETZ
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
12/20/2007
Decision Date
10/15/2008
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
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