FDA 510(k)

Breathe Easy Mobile Respiratory Monitor (MRM)

Номер K: K211387 · 2021-11-23

Дата решения2021-11-23

Код продуктаBZQ

Консультативный комитетAN

РешениеSubstantially Equivalent

Описание устройства

Breathe Easy Mobile Respiratory Monitor (MRM) is the device name listed in this FDA 510(k) record. The listed applicant is Sound Life Sciences, Inc.. It received FDA 510(k) clearance on 2021-11-23 under 510(k) number K211387. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Breathe Easy Mobile Respiratory Monitor (MRM)?

Breathe Easy Mobile Respiratory Monitor (MRM) is a medical device that received FDA 510(k) clearance on 2021-11-23. The listed applicant is Sound Life Sciences, Inc.. The 510(k) number is K211387.

When did Breathe Easy Mobile Respiratory Monitor (MRM) receive FDA 510(k) clearance?

Breathe Easy Mobile Respiratory Monitor (MRM) received FDA 510(k) clearance on 2021-11-23, under 510(k) number K211387.

Who is the listed applicant for Breathe Easy Mobile Respiratory Monitor (MRM)?

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

What is the FDA product code for Breathe Easy Mobile Respiratory Monitor (MRM)?

The FDA product code for Breathe Easy Mobile Respiratory Monitor (MRM) is BZQ.

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: BZQ)

K253274BedDot (G1)Intelligent Dots, LLC K251326Respiration Rate algorithmEdwards Lifesciences, LLC K250093Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.K243183RTMsense Respiratory Monitoring SystemRtm Vital Signs, LLC K243966FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)Faceheart Corp.

Официальный источник

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