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FDA 510(k)

Coaptium Connect with Tissium Light

Número K: K251957 · 2025-09-08

RequerenteTissium SA
Data da decisão2025-09-08
Código do produtoSFD
Comité consultivoNE
DecisãoSubstantially Equivalent

Resumo do dispositivo

Coaptium Connect with Tissium Light is the device name listed in this FDA 510(k) record. The listed applicant is Tissium SA. It received FDA 510(k) clearance on 2025-09-08 under 510(k) number K251957. The device is classified under product code SFD. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Coaptium Connect with Tissium Light?

Coaptium Connect with Tissium Light is a medical device that received FDA 510(k) clearance on 2025-09-08. The listed applicant is Tissium SA. The 510(k) number is K251957.

When did Coaptium Connect with Tissium Light receive FDA 510(k) clearance?

Coaptium Connect with Tissium Light received FDA 510(k) clearance on 2025-09-08, under 510(k) number K251957.

Who is the listed applicant for Coaptium Connect with Tissium Light?

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

What is the FDA product code for Coaptium Connect with Tissium Light?

The FDA product code for Coaptium Connect with Tissium Light is SFD.

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