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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, measurement, blood-pressure, non-invasive
510(k) Number K093802
Device Name ULTRAVIEW DM3 MONITOR
Applicant
ZOE MEDICAL, INC.
460 BOSTON ST.
TOPSFIELD,  MA  01983 -1223
Applicant Contact JIM CHICKERING
Correspondent
ZOE MEDICAL, INC.
460 BOSTON ST.
TOPSFIELD,  MA  01983 -1223
Correspondent Contact JIM CHICKERING
Regulation Number870.1130
Classification Product Code
DXN  
Subsequent Product Code
DQA  
Date Received12/11/2009
Decision Date 04/09/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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