Cleared Traditional

CLEWICU System (ClewICUServer and ClewICUnitor)

K200717 · Clew Medical , Ltd. · Cardiovascular
Jan 2021
Decision
297d
Days
Class 2
Risk

About This 510(k) Submission

K200717 is an FDA 510(k) clearance for the CLEWICU System (ClewICUServer and ClewICUnitor), a Medium-term Adjunctive Predictive Cardiovascular Indicator (Class II — Special Controls, product code QNL), submitted by Clew Medical , Ltd. (Netanya, IL). The FDA issued a Cleared decision on January 9, 2021, 297 days after receiving the submission on March 18, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2210.

Submission Details

510(k) Number K200717 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 2020
Decision Date January 09, 2021
Days to Decision 297 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code QNL — Medium-term Adjunctive Predictive Cardiovascular Indicator
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2210
Definition The Adjunctive Predictive Cardiovascular Indicator Is A Prescription Device That Uses Software Algorithms To Analyze Cardiovascular Vital Signs And Predict Future Cardiovascular Status Or Events Within A Defined Medium-term Period. This Device Is Intended For Adjunctive Use With Other Physical Vital Sign Parameters And Patient Information And Is Not Intended To Independently Direct Therapy.