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FDA 510(k)

Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R Tanning Canopy

Número K: K152423 · 2016-05-20

RequerenteSunfire Industries, Inc.
Data da decisão2016-05-20
Código do produtoLEJ
Comité consultivoSU
DecisãoSubstantially Equivalent

Resumo do dispositivo

Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R Tanning Canopy is the device name listed in this FDA 510(k) record. The listed applicant is Sunfire Industries, Inc.. It received FDA 510(k) clearance on 2016-05-20 under 510(k) number K152423. The device is classified under product code LEJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R Tanning Canopy?

Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R Tanning Canopy is a medical device that received FDA 510(k) clearance on 2016-05-20. The listed applicant is Sunfire Industries, Inc.. The 510(k) number is K152423.

When did Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R Tanning Canopy receive FDA 510(k) clearance?

Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R Tanning Canopy received FDA 510(k) clearance on 2016-05-20, under 510(k) number K152423.

Who is the listed applicant for Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R Tanning Canopy?

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

What is the FDA product code for Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R Tanning Canopy?

The FDA product code for Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R Tanning Canopy is LEJ.

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Fonte oficial

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