FDA 510(k)

Capsule Surveillance System

N.º K: K213335 · 2022-01-14

SolicitanteCapsule Surveillance Technologies, Sas /Capsule Tech, Inc.

Fecha de decisión2022-01-14

Código de productoMWI

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Capsule Surveillance System is the device name listed in this FDA 510(k) record. The listed applicant is Capsule Surveillance Technologies, Sas /Capsule Tech, Inc.. It received FDA 510(k) clearance on 2022-01-14 under 510(k) number K213335. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Capsule Surveillance System?

Capsule Surveillance System is a medical device that received FDA 510(k) clearance on 2022-01-14. The listed applicant is Capsule Surveillance Technologies, Sas /Capsule Tech, Inc.. The 510(k) number is K213335.

When did Capsule Surveillance System receive FDA 510(k) clearance?

Capsule Surveillance System received FDA 510(k) clearance on 2022-01-14, under 510(k) number K213335.

Who is the listed applicant for Capsule Surveillance System?

The FDA 510(k) record lists Capsule Surveillance Technologies, Sas /Capsule Tech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Capsule Surveillance System?

The FDA product code for Capsule Surveillance System is MWI.

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Fuente oficial

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