OmniTom Elite
K-Number: K202526 · 2020-12-23
Decision Date2020-12-23
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
OmniTom Elite is a medical device manufactured by Neurologica Corporation, A Subsidiary of Samsung Electronics. It received FDA 510(k) clearance on 2020-12-23 under approval number K202526. 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 2020-12-23. It is manufactured by Neurologica Corporation, A Subsidiary of Samsung Electronics. The 510(k) number is K202526.
When was OmniTom Elite approved by the FDA?
OmniTom Elite received FDA 510(k) clearance on 2020-12-23, under approval number K202526.
What company makes OmniTom Elite?
OmniTom Elite is manufactured by Neurologica Corporation, A Subsidiary of Samsung Electronics.
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 Electronics
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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.