FDA 510(k)

BodyGuardian Remote Monitoring System

N.º K: K192732 · 2020-03-26

SolicitantePreventice Technologies, Inc.

Fecha de decisión2020-03-26

Código de productoDSI

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

BodyGuardian Remote Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Preventice Technologies, Inc.. It received FDA 510(k) clearance on 2020-03-26 under 510(k) number K192732. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the BodyGuardian Remote Monitoring System?

BodyGuardian Remote Monitoring System is a medical device that received FDA 510(k) clearance on 2020-03-26. The listed applicant is Preventice Technologies, Inc.. The 510(k) number is K192732.

When did BodyGuardian Remote Monitoring System receive FDA 510(k) clearance?

BodyGuardian Remote Monitoring System received FDA 510(k) clearance on 2020-03-26, under 510(k) number K192732.

Who is the listed applicant for BodyGuardian Remote Monitoring System?

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

What is the FDA product code for BodyGuardian Remote Monitoring System?

The FDA product code for BodyGuardian Remote Monitoring System is DSI.

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Fuente oficial

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