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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 a medical device manufactured by Baxter Healthcare Corproration. It received FDA 510(k) clearance on 2022-11-18 under approval 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. It is manufactured by Baxter Healthcare Corproration. The 510(k) number is K223246.

When was Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense approved by the FDA?

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

What company makes Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense?

Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense is manufactured by Baxter Healthcare Corproration.

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.

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Related PubMed Literature

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Related Devices (Code: BZQ)

K152911EarlySense Insight SytemEarlysense, Ltd. K151940Thora-3Di, Model T-01Pneumacare Limited K173976Masimo Acoustic Respiration Sensors, infant and neonateMasimo Corporation K180079Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor ActivationHill-Rom, Inc. K171836EarlySense Bed Sensing UnitEarlysense, Ltd. K190775The RHEA Vital Sign Vigilance SystemShenzhen Fiber Medical Technology Co. , Ltd.

Official Source

View on FDA Database →

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

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