FDA 510(k)

Alio Medical Remote Monitoring System

Номер K: K211365 · 2022-03-24

Дата решения2022-03-24

Код продуктаDRG

Консультативный комитетCV

РешениеSubstantially Equivalent

Описание устройства

Alio Medical Remote Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Graftworx, Inc. Dba Alio. It received FDA 510(k) clearance on 2022-03-24 under 510(k) number K211365. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Alio Medical Remote Monitoring System?

Alio Medical Remote Monitoring System is a medical device that received FDA 510(k) clearance on 2022-03-24. The listed applicant is Graftworx, Inc. Dba Alio. The 510(k) number is K211365.

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

Alio Medical Remote Monitoring System received FDA 510(k) clearance on 2022-03-24, under 510(k) number K211365.

Who is the listed applicant for Alio Medical Remote Monitoring System?

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

What is the FDA product code for Alio Medical Remote Monitoring System?

The FDA product code for Alio Medical Remote Monitoring System is DRG.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: DRG)

K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC K252440EasyTeleMed (2.0.2)Ingeniars S.R.L.K250259TeleRehab Aermos Cardiopulmonary RehabilitationThe ScottCare Corporation K243837iBSMIorbit Digital Technologies Private Limited K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.

Официальный источник

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