FDA 510(k)

Disposable Belts for Polysomnography (CNSAC)

Номер K: K260949 · 2026-09-24

Дата решения2026-09-24

Код продуктаMNR

Консультативный комитетAN

РешениеSubstantially Equivalent

Описание устройства

Disposable Belts for Polysomnography (CNSAC) is the device name listed in this FDA 510(k) record. The listed applicant is CNSAC Medshop GmbH. It received FDA 510(k) clearance on 2026-09-24 under 510(k) number K260949. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Disposable Belts for Polysomnography (CNSAC)?

Disposable Belts for Polysomnography (CNSAC) is a medical device that received FDA 510(k) clearance on 2026-09-24. The listed applicant is CNSAC Medshop GmbH. The 510(k) number is K260949.

When did Disposable Belts for Polysomnography (CNSAC) receive FDA 510(k) clearance?

Disposable Belts for Polysomnography (CNSAC) received FDA 510(k) clearance on 2026-09-24, under 510(k) number K260949.

Who is the listed applicant for Disposable Belts for Polysomnography (CNSAC)?

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

What is the FDA product code for Disposable Belts for Polysomnography (CNSAC)?

The FDA product code for Disposable Belts for Polysomnography (CNSAC) is MNR.

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: MNR)

K254042WatchPAT SWItamar Medical , Ltd.K260050WRAP SystemHuneo, LLC K253148RX-1 SleepVivaquant, Inc. Dba Rhythm Express K252628CASSIEWesper, Inc.K252497SANSA HSATHuxley Medical K250882SANSA HSATHuxley Medical

Официальный источник

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