FDA 510(k)

T-Lite

K-Number: K201988 · 2020-10-30

Decision Date2020-10-30

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

T-Lite is a medical device manufactured by Sonoscanner. It received FDA 510(k) clearance on 2020-10-30 under approval number K201988. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the T-Lite?

T-Lite is a medical device that received FDA 510(k) clearance on 2020-10-30. It is manufactured by Sonoscanner. The 510(k) number is K201988.

When was T-Lite approved by the FDA?

T-Lite received FDA 510(k) clearance on 2020-10-30, under approval number K201988.

What company makes T-Lite?

T-Lite is manufactured by Sonoscanner.

What is the FDA product code for T-Lite?

The FDA product code for T-Lite is IYN.

Other Devices by Sonoscanner

K171164U-Lite EXP

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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.