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FDA 510(k)

Titan 3W

K-Number: K160835 · 2017-02-02

ApplicantTzora Active Systems , Ltd.
Decision Date2017-02-02
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Titan 3W is a medical device manufactured by Tzora Active Systems , Ltd.. It received FDA 510(k) clearance on 2017-02-02 under approval number K160835. The device is classified under product code INI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Titan 3W?

Titan 3W is a medical device that received FDA 510(k) clearance on 2017-02-02. It is manufactured by Tzora Active Systems , Ltd.. The 510(k) number is K160835.

When was Titan 3W approved by the FDA?

Titan 3W received FDA 510(k) clearance on 2017-02-02, under approval number K160835.

What company makes Titan 3W?

Titan 3W is manufactured by Tzora Active Systems , Ltd..

What is the FDA product code for Titan 3W?

The FDA product code for Titan 3W is INI.

Other Devices by Tzora Active Systems , Ltd.

K172409Lite

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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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