U-Lite EXP
K-Number: K171164 · 2017-08-03
ApplicantSonoscanner
Decision Date2017-08-03
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
U-Lite EXP is a medical device manufactured by Sonoscanner. It received FDA 510(k) clearance on 2017-08-03 under approval 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. It is manufactured by Sonoscanner. The 510(k) number is K171164.
When was U-Lite EXP approved by the FDA?
U-Lite EXP received FDA 510(k) clearance on 2017-08-03, under approval number K171164.
What company makes U-Lite EXP?
U-Lite EXP is manufactured by Sonoscanner.
What is the FDA product code for U-Lite EXP?
The FDA product code for U-Lite EXP is IYN.
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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.