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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lung Sound Monitor
510(k) Number K073582
Device Name VRIICU SYSTEM
Applicant
Deep Breeze , Ltd.
2001 Pennsylvania Ave. NW, Suite 950
Washington,  DC  20006
Applicant Contact JEFF BAETZ
Correspondent
Deep Breeze , Ltd.
2001 Pennsylvania Ave. NW, Suite 950
Washington,  DC  20006
Correspondent Contact JEFF BAETZ
Regulation Number870.1875
Classification Product Code
OCR  
Date Received12/20/2007
Decision Date 10/15/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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