CLEWICU System (ClewICUServer And ClewICUnitor)

Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

CLEW Medical Ltd.

The following data is part of a premarket notification filed by Clew Medical Ltd. with the FDA for Clewicu System (clewicuserver And Clewicunitor).

Pre-market Notification Details

Device IDK200717
510k NumberK200717
Device Name:CLEWICU System (ClewICUServer And ClewICUnitor)
ClassificationMonitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Applicant CLEW Medical Ltd. 5 Hamelacha St. Netanya,  IL 4206002
ContactAvigdor Faians
CorrespondentYarmela Pavlovic
Manatt, Phelps & Phillips, LLP 1 Embarcadero Center, 30th Floor San Francisco,  CA  94111
Product CodeMWI  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-18
Decision Date2021-01-09

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