OmniTom
K-Number: K171183 · 2017-08-18
ApplicantNeurologica Corporation
Decision Date2017-08-18
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
OmniTom is a medical device manufactured by Neurologica Corporation. It received FDA 510(k) clearance on 2017-08-18 under approval number K171183. 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?
OmniTom is a medical device that received FDA 510(k) clearance on 2017-08-18. It is manufactured by Neurologica Corporation. The 510(k) number is K171183.
When was OmniTom approved by the FDA?
OmniTom received FDA 510(k) clearance on 2017-08-18, under approval number K171183.
What company makes OmniTom?
OmniTom is manufactured by Neurologica Corporation.
What is the FDA product code for OmniTom?
The FDA product code for OmniTom 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.