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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
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