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FDA 510(k)

Titan 3W

K-Number: K160835 · 2017-02-02

Decision Date2017-02-02
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Titan 3W is the device name listed in this FDA 510(k) record. The listed applicant is Tzora Active Systems , Ltd.. It received FDA 510(k) clearance on 2017-02-02 under 510(k) 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. The listed applicant is Tzora Active Systems , Ltd.. The 510(k) number is K160835.

When did Titan 3W receive FDA 510(k) clearance?

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

Who is the listed applicant for Titan 3W?

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

What is the FDA product code for Titan 3W?

The FDA product code for Titan 3W is INI.

Other records listing Tzora Active Systems , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: INI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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