FDA 510(k)

Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense

Номер K: K223246 · 2022-11-18

Дата решения2022-11-18

Код продуктаBZQ

Консультативный комитетAN

РешениеSubstantially Equivalent

Описание устройства

Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corproration. It received FDA 510(k) clearance on 2022-11-18 under 510(k) number K223246. 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 Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense?

Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense is a medical device that received FDA 510(k) clearance on 2022-11-18. The listed applicant is Baxter Healthcare Corproration. The 510(k) number is K223246.

When did Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense receive FDA 510(k) clearance?

Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense received FDA 510(k) clearance on 2022-11-18, under 510(k) number K223246.

Who is the listed applicant for Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense?

The FDA 510(k) record lists Baxter Healthcare Corproration as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense?

The FDA product code for Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense 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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