FDA 510(k)

eMotus Respiratory Motion Management System

Номер K: K243900 · 2025-06-27

ЗаявительEmpnia, Inc.

Дата решения2025-06-27

Код продуктаLHN

Консультативный комитетRA

РешениеSubstantially Equivalent

Описание устройства

eMotus Respiratory Motion Management System is the device name listed in this FDA 510(k) record. The listed applicant is Empnia, Inc.. It received FDA 510(k) clearance on 2025-06-27 under 510(k) number K243900. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the eMotus Respiratory Motion Management System?

eMotus Respiratory Motion Management System is a medical device that received FDA 510(k) clearance on 2025-06-27. The listed applicant is Empnia, Inc.. The 510(k) number is K243900.

When did eMotus Respiratory Motion Management System receive FDA 510(k) clearance?

eMotus Respiratory Motion Management System received FDA 510(k) clearance on 2025-06-27, under 510(k) number K243900.

Who is the listed applicant for eMotus Respiratory Motion Management System?

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

What is the FDA product code for eMotus Respiratory Motion Management System?

The FDA product code for eMotus Respiratory Motion Management System is LHN.

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: LHN)

K260597VIRTUE QAProNova Solutions K260174PROBEAT-CRHitachi High-Tech Corp.K252815ProBeam 360 Proton Therapy System v3.0Varian Medical Systems, Inc.K253406S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc.K250986S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc.K242418P-Cure Proton Therapy System (PPTS)P-Cure, Ltd.

Официальный источник

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