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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 the device name listed in this FDA 510(k) record. The listed applicant is Oxitone Medical , Ltd.. It received FDA 510(k) clearance on 2017-05-09 under 510(k) 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. The listed applicant is Oxitone Medical , Ltd.. The 510(k) number is K163382.

When did Oxitone 1000 receive FDA 510(k) clearance?

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

Who is the listed applicant for Oxitone 1000?

The FDA 510(k) record lists Oxitone Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Oxitone 1000?

The FDA product code for Oxitone 1000 is DQA.

Related Devices (Code: DQA)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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