Lite
K-Number: K172409 · 2018-05-02
ApplicantTzora Active Systems , Ltd.
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.
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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.