FDA 510(k)

CLEWICU System

K-Number: K233216 · 2024-01-13

Decision Date2024-01-13

Product CodeQNL

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CLEWICU System is the device name listed in this FDA 510(k) record. The listed applicant is Clew Medical , Ltd.. It received FDA 510(k) clearance on 2024-01-13 under 510(k) 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. The listed applicant is Clew Medical , Ltd.. The 510(k) number is K233216.

When did CLEWICU System receive FDA 510(k) clearance?

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

Who is the listed applicant for CLEWICU System?

The FDA 510(k) record lists Clew Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLEWICU System?

The FDA product code for CLEWICU System is QNL.

Other records listing Clew Medical , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K200717CLEWICU System (ClewICUServer and ClewICUnitor)

Related Devices (Code: QNL)

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

Official Source

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