CLEWICU System (ClewICUServer and ClewICUnitor)— 510(k) K200717

Name: FDA 510(k) clearance K200717
Creator: U.S. Food and Drug Administration
Published: 2021-01-09

Substantially Equivalent

Clew Medical , Ltd.

FDA 510(k) clearance K200717 for CLEWICU System (ClewICUServer and ClewICUnitor), Substantially Equivalent on 2021-01-09. Applicant: Clew Medical , Ltd.. Device class: 2.

Clearance details

Applicant: Clew Medical , Ltd.
Product code: Code QNL
Device class: Class 2
Regulation: 21 CFR 870.2210
Advisory panel: Cardiovascular
Date received: 2020-03-18
Decision date: 2021-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Netanya, IL

Download summary PDF View on FDA.gov ↗

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