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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 K172457
Device Name Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM
Applicant
Deltex Medical Limited
Terminus Rd.
Chichester,  GB PO19 8TX
Applicant Contact Mark Baylis
Correspondent
Deltex Medical Limited
Terminus Rd.
Chichester,  GB PO19 8TX
Correspondent Contact Mark Baylis
Regulation Number870.2100
Classification Product Code
DPW  
Date Received08/14/2017
Decision Date 06/28/2018
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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