FDA 510(k)

TeleRehab Aermos Cardiopulmonary Rehabilitation

Номер K: K250259 · 2025-06-04

Дата решения2025-06-04

Код продуктаDRG

Консультативный комитетCV

РешениеSubstantially Equivalent

Описание устройства

TeleRehab Aermos Cardiopulmonary Rehabilitation is the device name listed in this FDA 510(k) record. The listed applicant is The ScottCare Corporation. It received FDA 510(k) clearance on 2025-06-04 under 510(k) number K250259. 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 TeleRehab Aermos Cardiopulmonary Rehabilitation?

TeleRehab Aermos Cardiopulmonary Rehabilitation is a medical device that received FDA 510(k) clearance on 2025-06-04. The listed applicant is The ScottCare Corporation. The 510(k) number is K250259.

When did TeleRehab Aermos Cardiopulmonary Rehabilitation receive FDA 510(k) clearance?

TeleRehab Aermos Cardiopulmonary Rehabilitation received FDA 510(k) clearance on 2025-06-04, under 510(k) number K250259.

Who is the listed applicant for TeleRehab Aermos Cardiopulmonary Rehabilitation?

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

What is the FDA product code for TeleRehab Aermos Cardiopulmonary Rehabilitation?

The FDA product code for TeleRehab Aermos Cardiopulmonary Rehabilitation 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.K243837iBSMIorbit Digital Technologies Private Limited K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.K241101BioButton SystemBiointellisense, Inc.

Официальный источник

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