EOlife®
K-Number: K221841 · 2023-03-18
ApplicantArcheon
Decision Date2023-03-18
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
EOlife® is the device name listed in this FDA 510(k) record. The listed applicant is Archeon. It received FDA 510(k) clearance on 2023-03-18 under 510(k) number K221841. The device is classified under product code BTM. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EOlife®?
EOlife® is a medical device that received FDA 510(k) clearance on 2023-03-18. The listed applicant is Archeon. The 510(k) number is K221841.
When did EOlife® receive FDA 510(k) clearance?
EOlife® received FDA 510(k) clearance on 2023-03-18, under 510(k) number K221841.
Who is the listed applicant for EOlife®?
The FDA 510(k) record lists Archeon as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EOlife®?
The FDA product code for EOlife® is BTM.
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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.