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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 K061495
Device Name VR LUNG ELECTROSONOGRAPH
Applicant
DEEP BREEZE LTD.
2001 PENNSYLVANIA AVENUE NW
SUITE 575
WASHINGTON,  DC  20006
Applicant Contact PHILIP J PHILLIPS
Correspondent
DEEP BREEZE LTD.
2001 PENNSYLVANIA AVENUE NW
SUITE 575
WASHINGTON,  DC  20006
Correspondent Contact PHILIP J PHILLIPS
Regulation Number870.1875
Classification Product Code
OCR  
Date Received05/31/2006
Decision Date 07/18/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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