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FDA 510(k)

Oxitone 1000

K-Number: K163382 · 2017-05-09

ApplicantOxitone Medical , Ltd.
Decision Date2017-05-09
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Oxitone 1000 is a medical device manufactured by Oxitone Medical , Ltd.. It received FDA 510(k) clearance on 2017-05-09 under approval number K163382. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Oxitone 1000?

Oxitone 1000 is a medical device that received FDA 510(k) clearance on 2017-05-09. It is manufactured by Oxitone Medical , Ltd.. The 510(k) number is K163382.

When was Oxitone 1000 approved by the FDA?

Oxitone 1000 received FDA 510(k) clearance on 2017-05-09, under approval number K163382.

What company makes Oxitone 1000?

Oxitone 1000 is manufactured by Oxitone Medical , Ltd..

What is the FDA product code for Oxitone 1000?

The FDA product code for Oxitone 1000 is DQA.

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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.

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