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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Flowmeter, Blood, Cardiovascular
510(k) Number K150347
Device Name Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+
Applicant
DELTEX MEDICAL LIMITED
TERMINUS RD.
CHICHESTER,  GB PO19 8TX
Applicant Contact Paul Dwane
Correspondent
MeddiQuest Limited
Quest Science
Herlington House, Orton Malborne
Peterborough,  GB pe2 5xs
Correspondent Contact Neil Armstrong
Regulation Number870.2100
Classification Product Code
DPW  
Date Received02/11/2015
Decision Date 07/24/2015
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
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