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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 K091732
Device Name VRLXP, MODEL XP
Applicant
DEEP BREEZE LTD.
2001 PENNSYLVANIA AVENUE NW
SUITE 950
WASHINGTON,  DC  20006
Applicant Contact JEFF BAETZ
Correspondent
DEEP BREEZE LTD.
2001 PENNSYLVANIA AVENUE NW
SUITE 950
WASHINGTON,  DC  20006
Correspondent Contact JEFF BAETZ
Regulation Number870.1875
Classification Product Code
OCR  
Date Received06/11/2009
Decision Date 03/04/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Clinical Trials NCT00473291
NCT00495430
NCT00506467
NCT00542282
NCT00672893
Reviewed by Third Party No
Combination Product No
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