Decision Date2022-07-29
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Next Generation NetKonnect is a medical device manufactured by Nihon Kohden Digital Health Solutions, Inc.. It received FDA 510(k) clearance on 2022-07-29 under approval number K220989. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Next Generation NetKonnect?
Next Generation NetKonnect is a medical device that received FDA 510(k) clearance on 2022-07-29. It is manufactured by Nihon Kohden Digital Health Solutions, Inc.. The 510(k) number is K220989.
When was Next Generation NetKonnect approved by the FDA?
Next Generation NetKonnect received FDA 510(k) clearance on 2022-07-29, under approval number K220989.
What company makes Next Generation NetKonnect?
Next Generation NetKonnect is manufactured by Nihon Kohden Digital Health Solutions, Inc..
What is the FDA product code for Next Generation NetKonnect?
The FDA product code for Next Generation NetKonnect is MHX.
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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.