FDA 510(k)

LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L

Номер K: K170565 · 2017-08-01

Дата решения2017-08-01

Код продуктаQYX

Консультативный комитетCV

РешениеSubstantially Equivalent

Описание устройства

LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L is the device name listed in this FDA 510(k) record. The listed applicant is Lifewatch Services, Inc.. It received FDA 510(k) clearance on 2017-08-01 under 510(k) number K170565. The device is classified under product code QYX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L?

LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L is a medical device that received FDA 510(k) clearance on 2017-08-01. The listed applicant is Lifewatch Services, Inc.. The 510(k) number is K170565.

When did LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L receive FDA 510(k) clearance?

LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L received FDA 510(k) clearance on 2017-08-01, under 510(k) number K170565.

Who is the listed applicant for LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L?

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

What is the FDA product code for LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L?

The FDA product code for LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L is QYX.

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: QYX)

K250793RhythmStar System (SL)RhythMedix, LLC K241179Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)VivaQuant, Inc.K240653SmartCardia 7L Platform (MCT)Smartcardia SA K240029Zio AT® device (A100A1001)iRhythm Technologies, Inc.K233584RhythmStar SystemRhythMedix, LLC K162956NOWCARDIO SYSTEMContex International Technologies (Canada), Inc.

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