CLEWICU System (ClewICUServer and ClewICUnitor)
K-Number: K200717 · 2021-01-09
ApplicantClew Medical , Ltd.
Decision Date2021-01-09
Product CodeQNL
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
CLEWICU System (ClewICUServer and ClewICUnitor) is a medical device manufactured by Clew Medical , Ltd.. It received FDA 510(k) clearance on 2021-01-09 under approval number K200717. 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 (ClewICUServer and ClewICUnitor)?
CLEWICU System (ClewICUServer and ClewICUnitor) is a medical device that received FDA 510(k) clearance on 2021-01-09. It is manufactured by Clew Medical , Ltd.. The 510(k) number is K200717.
When was CLEWICU System (ClewICUServer and ClewICUnitor) approved by the FDA?
CLEWICU System (ClewICUServer and ClewICUnitor) received FDA 510(k) clearance on 2021-01-09, under approval number K200717.
What company makes CLEWICU System (ClewICUServer and ClewICUnitor)?
CLEWICU System (ClewICUServer and ClewICUnitor) is manufactured by Clew Medical , Ltd..
What is the FDA product code for CLEWICU System (ClewICUServer and ClewICUnitor)?
The FDA product code for CLEWICU System (ClewICUServer and ClewICUnitor) is QNL.
Other Devices by Clew Medical , Ltd.
Related Devices (Code: QNL)
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.