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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 K051145
Device Name CRITIVIEW
Applicant
Critisense , Ltd.
6329 W.Waterview Ct.
Mccordsville,  IN  46055 -9501
Applicant Contact PAUL E DRYDEN
Correspondent
Critisense , Ltd.
6329 W.Waterview Ct.
Mccordsville,  IN  46055 -9501
Correspondent Contact PAUL E DRYDEN
Regulation Number870.2100
Classification Product Code
DPW  
Subsequent Product Code
KHO  
Date Received05/04/2005
Decision Date 01/18/2006
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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