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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 K010049
Device Name PULSECO HEMODYNAMIC MONITOR CM71
Applicant
Lidco, Ltd.
16 Orsman Rd.
London,  GB N1 5QJ
Applicant Contact GREGORY SPELLER
Correspondent
Lidco, Ltd.
16 Orsman Rd.
London,  GB N1 5QJ
Correspondent Contact GREGORY SPELLER
Regulation Number870.1435
Classification Product Code
DXG  
Date Received01/05/2001
Decision Date 06/14/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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