OmniTom Elite
K-Number: K233767 · 2024-06-10
ApplicantNeurologica Corporation
Decision Date2024-06-10
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
OmniTom Elite is a medical device manufactured by Neurologica Corporation. It received FDA 510(k) clearance on 2024-06-10 under approval number K233767. 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 2024-06-10. It is manufactured by Neurologica Corporation. The 510(k) number is K233767.
When was OmniTom Elite approved by the FDA?
OmniTom Elite received FDA 510(k) clearance on 2024-06-10, under approval number K233767.
What company makes OmniTom Elite?
OmniTom Elite is manufactured by Neurologica Corporation.
What is the FDA product code for OmniTom Elite?
The FDA product code for OmniTom Elite is JAK.
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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.