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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name computer, diagnostic, pre-programmed, single-function
510(k) Number K163334
Device Name LiDCOunity v2 Hemodynamic Monitor
Applicant
LiDCO Ltd
16 ORSMAN ROAD
LONDON,  GB N1 5QJ
Applicant Contact JI HEE KO
Correspondent
LiDCO Ltd
16 ORSMAN ROAD
LONDON,  GB N1 5QJ
Correspondent Contact JI HEE KO
Regulation Number870.1435
Classification Product Code
DXG  
Subsequent Product Codes
DXN   GWQ  
Date Received11/28/2016
Decision Date 06/05/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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