FDA 510(k)

mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7)

Номер K: K253384 · 2026-06-25

Дата решения2026-06-25

Код продуктаMWJ

Консультативный комитетCV

РешениеSubstantially Equivalent

Описание устройства

mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7) is the device name listed in this FDA 510(k) record. The listed applicant is Seers Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-06-25 under 510(k) number K253384. The device is classified under product code MWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7)?

mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7) is a medical device that received FDA 510(k) clearance on 2026-06-25. The listed applicant is Seers Technology Co., Ltd.. The 510(k) number is K253384.

When did mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7) receive FDA 510(k) clearance?

mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7) received FDA 510(k) clearance on 2026-06-25, under 510(k) number K253384.

Who is the listed applicant for mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7)?

The FDA 510(k) record lists Seers Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7)?

The FDA product code for mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7) is MWJ.

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: MWJ)

Официальный источник

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