FDA 510(k)

U-Lite EXP

K-Number: K171164 · 2017-08-03

Decision Date2017-08-03

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

U-Lite EXP is the device name listed in this FDA 510(k) record. The listed applicant is Sonoscanner. It received FDA 510(k) clearance on 2017-08-03 under 510(k) number K171164. 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 U-Lite EXP?

U-Lite EXP is a medical device that received FDA 510(k) clearance on 2017-08-03. The listed applicant is Sonoscanner. The 510(k) number is K171164.

When did U-Lite EXP receive FDA 510(k) clearance?

U-Lite EXP received FDA 510(k) clearance on 2017-08-03, under 510(k) number K171164.

Who is the listed applicant for U-Lite EXP?

The FDA 510(k) record lists Sonoscanner as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for U-Lite EXP?

The FDA product code for U-Lite EXP is IYN.

Other records listing Sonoscanner 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.

K201988T-Lite

Related Devices (Code: IYN)

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.