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FDA 510(k)

Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense

K-Number: K223246 · 2022-11-18

ApplicantBaxter Healthcare Corproration
Decision Date2022-11-18
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07223931Validating Dozee for Contactless Monitoring of Heart, Breathing, and MovemenCOMPLETEDNCT07704320Clinical Assessment of the BreathAlert Device in Monitoring Apneic EpisodesRECRUITINGNCT07735403Dozee Validation for Contactless Heart Rate and Respiration Monitoring in Clinical SettingsRECRUITING

Related Devices (Code: BZQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253274BedDot (G1)Intelligent Dots, LLCK251326Respiration Rate algorithmEdwards Lifesciences, LLCK250093Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.K243183RTMsense Respiratory Monitoring SystemRtm Vital Signs, LLCK243966FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)Faceheart Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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