FDA 510(k)

SoundBite Crossing System - Peripheral (14P)

Número K: K210839 · 2021-04-20

RequerenteSoundbite Medical Solutions, Inc.

Data da decisão2021-04-20

Código do produtoPDU

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

SoundBite Crossing System - Peripheral (14P) is the device name listed in this FDA 510(k) record. The listed applicant is Soundbite Medical Solutions, Inc.. It received FDA 510(k) clearance on 2021-04-20 under 510(k) number K210839. The device is classified under product code PDU. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SoundBite Crossing System - Peripheral (14P)?

SoundBite Crossing System - Peripheral (14P) is a medical device that received FDA 510(k) clearance on 2021-04-20. The listed applicant is Soundbite Medical Solutions, Inc.. The 510(k) number is K210839.

When did SoundBite Crossing System - Peripheral (14P) receive FDA 510(k) clearance?

SoundBite Crossing System - Peripheral (14P) received FDA 510(k) clearance on 2021-04-20, under 510(k) number K210839.

Who is the listed applicant for SoundBite Crossing System - Peripheral (14P)?

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

What is the FDA product code for SoundBite Crossing System - Peripheral (14P)?

The FDA product code for SoundBite Crossing System - Peripheral (14P) is PDU.

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Outros registros que listam Soundbite Medical Solutions, Inc. como candidato(a)

K230159SoundBite® Crossing System XS Peripheral

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Fonte oficial

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