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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 K152935
Device Name LiDCOunity Monitor
Applicant
Lidco, Ltd.
16 Orsman Rd.
London,  GB N1 5QJ
Applicant Contact ERIC MILLS
Correspondent
Lidco, Ltd.
16 Orsman Rd.
London,  GB N1 5QJ
Correspondent Contact ERIC MILLS
Regulation Number870.1435
Classification Product Code
DXG  
Subsequent Product Code
GWQ  
Date Received10/05/2015
Decision Date 03/17/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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