InBody
K-Number: K200442 · 2020-12-04
ApplicantInbody Co., Ltd.
Decision Date2020-12-04
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
InBody is a medical device manufactured by Inbody Co., Ltd.. It received FDA 510(k) clearance on 2020-12-04 under approval number K200442. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the InBody?
InBody is a medical device that received FDA 510(k) clearance on 2020-12-04. It is manufactured by Inbody Co., Ltd.. The 510(k) number is K200442.
When was InBody approved by the FDA?
InBody received FDA 510(k) clearance on 2020-12-04, under approval number K200442.
What company makes InBody?
InBody is manufactured by Inbody Co., Ltd..
What is the FDA product code for InBody?
The FDA product code for InBody is DXN.
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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.