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FDA 510(k)

i8 Tanning Booth

K-Number: K210004 · 2021-12-10

ApplicantUltrasun International B.V.
Decision Date2021-12-10
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

i8 Tanning Booth is a medical device manufactured by Ultrasun International B.V.. It received FDA 510(k) clearance on 2021-12-10 under approval number K210004. The device is classified under product code FTC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the i8 Tanning Booth?

i8 Tanning Booth is a medical device that received FDA 510(k) clearance on 2021-12-10. It is manufactured by Ultrasun International B.V.. The 510(k) number is K210004.

When was i8 Tanning Booth approved by the FDA?

i8 Tanning Booth received FDA 510(k) clearance on 2021-12-10, under approval number K210004.

What company makes i8 Tanning Booth?

i8 Tanning Booth is manufactured by Ultrasun International B.V..

What is the FDA product code for i8 Tanning Booth?

The FDA product code for i8 Tanning Booth is FTC.

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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.

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