FDA 510(k)

BLESSING System

Número K: K243176 · 2025-05-16

Data da decisão2025-05-16

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

BLESSING System is the device name listed in this FDA 510(k) record. The listed applicant is Cellah Medical Co., Ltd.. It received FDA 510(k) clearance on 2025-05-16 under 510(k) number K243176. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BLESSING System?

BLESSING System is a medical device that received FDA 510(k) clearance on 2025-05-16. The listed applicant is Cellah Medical Co., Ltd.. The 510(k) number is K243176.

When did BLESSING System receive FDA 510(k) clearance?

BLESSING System received FDA 510(k) clearance on 2025-05-16, under 510(k) number K243176.

Who is the listed applicant for BLESSING System?

The FDA 510(k) record lists Cellah Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BLESSING System?

The FDA product code for BLESSING System is GEI.

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