FDA 510(k)

i8 Tanning Booth

Número K: K210004 · 2021-12-10

Data da decisão2021-12-10

Código do produtoFTC

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

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

Perguntas frequentes

What is the i8 Tanning Booth?

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

When did i8 Tanning Booth receive FDA 510(k) clearance?

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

Who is the listed applicant for i8 Tanning Booth?

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

What is the FDA product code for i8 Tanning Booth?

The FDA product code for i8 Tanning Booth is FTC.

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