OmniTom Elite
K-Number: K223447 · 2023-06-01
Decision Date2023-06-01
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
OmniTom Elite is a medical device manufactured by Neurologica Corporation, A Subsidiary of Samsung. It received FDA 510(k) clearance on 2023-06-01 under approval number K223447. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the OmniTom Elite?
OmniTom Elite is a medical device that received FDA 510(k) clearance on 2023-06-01. It is manufactured by Neurologica Corporation, A Subsidiary of Samsung. The 510(k) number is K223447.
When was OmniTom Elite approved by the FDA?
OmniTom Elite received FDA 510(k) clearance on 2023-06-01, under approval number K223447.
What company makes OmniTom Elite?
OmniTom Elite is manufactured by Neurologica Corporation, A Subsidiary of Samsung.
What is the FDA product code for OmniTom Elite?
The FDA product code for OmniTom Elite is JAK.
Other Devices by Neurologica Corporation, A Subsidiary of Samsung
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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.