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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Medium-Term Adjunctive Predictive Cardiovascular Indicator
510(k) Number K200717
Device Name CLEWICU System (ClewICUServer and ClewICUnitor)
Applicant
Clew Medical , Ltd.
5 Hamelacha St.
Netanya,  IL 4206002
Applicant Contact Avigdor Faians
Correspondent
Manatt, Phelps, & Phillips, Llp
1 Embarcadero Center
30th Floor
San Francisco,  CA  94111
Correspondent Contact Yarmela Pavlovic
Regulation Number870.2210
Classification Product Code
QNL  
Date Received03/18/2020
Decision Date 01/09/2021
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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