FDA 510(k)

GEM

N.º K: K213385 · 2022-07-01

Fecha de decisión2022-07-01

Código de productoKRD

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

GEM is the device name listed in this FDA 510(k) record. The listed applicant is Obsidio, Inc.. It received FDA 510(k) clearance on 2022-07-01 under 510(k) number K213385. The device is classified under product code KRD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the GEM?

GEM is a medical device that received FDA 510(k) clearance on 2022-07-01. The listed applicant is Obsidio, Inc.. The 510(k) number is K213385.

When did GEM receive FDA 510(k) clearance?

GEM received FDA 510(k) clearance on 2022-07-01, under 510(k) number K213385.

Who is the listed applicant for GEM?

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

What is the FDA product code for GEM?

The FDA product code for GEM is KRD.

Literatura relacionada en PubMed

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Fuente oficial

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