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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 K023960
Device Name LIDCOPLUS HEMODYNAMIC MONITOR SYSTEM, MODEL HM 70
Applicant
LIDCO LTD.
16 ORSMAN RD.
LONDON,  GB N15QJ
Applicant Contact GREGORY SPELLER
Correspondent
LIDCO LTD.
16 ORSMAN RD.
LONDON,  GB N15QJ
Correspondent Contact GREGORY SPELLER
Regulation Number870.1435
Classification Product Code
DXG  
Date Received11/29/2002
Decision Date 01/09/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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