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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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