OmniTom Elite with PCD
K-Number: K250928 · 2025-09-08
ApplicantNeurologica Corporation
Decision Date2025-09-08
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
OmniTom Elite with PCD is a medical device manufactured by Neurologica Corporation. It received FDA 510(k) clearance on 2025-09-08 under approval number K250928. 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 with PCD?
OmniTom Elite with PCD is a medical device that received FDA 510(k) clearance on 2025-09-08. It is manufactured by Neurologica Corporation. The 510(k) number is K250928.
When was OmniTom Elite with PCD approved by the FDA?
OmniTom Elite with PCD received FDA 510(k) clearance on 2025-09-08, under approval number K250928.
What company makes OmniTom Elite with PCD?
OmniTom Elite with PCD is manufactured by Neurologica Corporation.
What is the FDA product code for OmniTom Elite with PCD?
The FDA product code for OmniTom Elite with PCD 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.