Erchonia FX-405
K-Number: K212595 · 2021-11-12
ApplicantErchonia Corporation
Decision Date2021-11-12
Product CodeNHN
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Erchonia FX-405 is a medical device manufactured by Erchonia Corporation. It received FDA 510(k) clearance on 2021-11-12 under approval number K212595. The device is classified under product code NHN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Erchonia FX-405?
Erchonia FX-405 is a medical device that received FDA 510(k) clearance on 2021-11-12. It is manufactured by Erchonia Corporation. The 510(k) number is K212595.
When was Erchonia FX-405 approved by the FDA?
Erchonia FX-405 received FDA 510(k) clearance on 2021-11-12, under approval number K212595.
What company makes Erchonia FX-405?
Erchonia FX-405 is manufactured by Erchonia Corporation.
What is the FDA product code for Erchonia FX-405?
The FDA product code for Erchonia FX-405 is NHN.
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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.