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FDA 510(k)

CLEWICU System

K-Number: K233216 · 2024-01-13

ApplicantClew Medical , Ltd.
Decision Date2024-01-13
Product CodeQNL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CLEWICU System is a medical device manufactured by Clew Medical , Ltd.. It received FDA 510(k) clearance on 2024-01-13 under approval number K233216. The device is classified under product code QNL. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLEWICU System?

CLEWICU System is a medical device that received FDA 510(k) clearance on 2024-01-13. It is manufactured by Clew Medical , Ltd.. The 510(k) number is K233216.

When was CLEWICU System approved by the FDA?

CLEWICU System received FDA 510(k) clearance on 2024-01-13, under approval number K233216.

What company makes CLEWICU System?

CLEWICU System is manufactured by Clew Medical , Ltd..

What is the FDA product code for CLEWICU System?

The FDA product code for CLEWICU System is QNL.

Other Devices by Clew Medical , Ltd.

K200717CLEWICU System (ClewICUServer and ClewICUnitor)

Related Devices (Code: QNL)

K200717CLEWICU System (ClewICUServer and ClewICUnitor)Clew Medical , Ltd. K230842SignalHF (IM008)Implicity, Inc. K231038Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLC K233253eCARTv5 Clinical Deterioration Suite (“eCART”)Agilemd, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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