CHIKAI Nexus 014
K-Number: K243383 · 2025-04-21
ApplicantAsahi Intecc Co., Ltd.
Decision Date2025-04-21
Product CodeMOF
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
CHIKAI Nexus 014 is a medical device manufactured by Asahi Intecc Co., Ltd.. It received FDA 510(k) clearance on 2025-04-21 under approval number K243383. The device is classified under product code MOF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CHIKAI Nexus 014?
CHIKAI Nexus 014 is a medical device that received FDA 510(k) clearance on 2025-04-21. It is manufactured by Asahi Intecc Co., Ltd.. The 510(k) number is K243383.
When was CHIKAI Nexus 014 approved by the FDA?
CHIKAI Nexus 014 received FDA 510(k) clearance on 2025-04-21, under approval number K243383.
What company makes CHIKAI Nexus 014?
CHIKAI Nexus 014 is manufactured by Asahi Intecc Co., Ltd..
What is the FDA product code for CHIKAI Nexus 014?
The FDA product code for CHIKAI Nexus 014 is MOF.
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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.