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FDA 510(k)

Lite

K-Number: K172409 · 2018-05-02

Decision Date2018-05-02
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Lite is a medical device manufactured by Tzora Active Systems , Ltd.. It received FDA 510(k) clearance on 2018-05-02 under approval number K172409. 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 Lite?

Lite is a medical device that received FDA 510(k) clearance on 2018-05-02. It is manufactured by Tzora Active Systems , Ltd.. The 510(k) number is K172409.

When was Lite approved by the FDA?

Lite received FDA 510(k) clearance on 2018-05-02, under approval number K172409.

What company makes Lite?

Lite is manufactured by Tzora Active Systems , Ltd..

What is the FDA product code for Lite?

The FDA product code for Lite is INI.

Other Devices by Tzora Active Systems , Ltd.

Related Devices (Code: INI)

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.