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FDA 510(k)

Respiree Cardio-Respiratory Monitor

K-Number: K223681 · 2023-03-08

ApplicantRespiree Pte, Ltd.
Decision Date2023-03-08
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Respiree Cardio-Respiratory Monitor is a medical device manufactured by Respiree Pte, Ltd.. It received FDA 510(k) clearance on 2023-03-08 under approval number K223681. 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 Respiree Cardio-Respiratory Monitor?

Respiree Cardio-Respiratory Monitor is a medical device that received FDA 510(k) clearance on 2023-03-08. It is manufactured by Respiree Pte, Ltd.. The 510(k) number is K223681.

When was Respiree Cardio-Respiratory Monitor approved by the FDA?

Respiree Cardio-Respiratory Monitor received FDA 510(k) clearance on 2023-03-08, under approval number K223681.

What company makes Respiree Cardio-Respiratory Monitor?

Respiree Cardio-Respiratory Monitor is manufactured by Respiree Pte, Ltd..

What is the FDA product code for Respiree Cardio-Respiratory Monitor?

The FDA product code for Respiree Cardio-Respiratory Monitor is BZQ.

Related Clinical Trials

NCT05452226 Neuromuscular Electrical Stimulation in COPD/Community Acquired Pneumonia COMPLETED NCT07405333 Effect of Coughing Exercises Versus Incentive Spirometry on Respiratory Function and Recovery in Children After Cardiac Surgery. RECRUITING NCT07552025 Detection of Respiratory Events Using Acoustic Monitoring in Extremely Preterm Infants NOT_YET_RECRUITING NCT06969560 WeRoaM: Wearable Remote Monitoring in Heart Failure RECRUITING NCT06732050 Influence of Intraoperative Nociception Guided Analgesia on Perioperative Total Analgesic Requirement Endometriosis COMPLETED NCT06321471 AeviceMD for Pediatric Asthma Management ACTIVE_NOT_RECRUITING

Other Devices by Respiree Pte, Ltd.

K250934Respiree Cardio- Respiratory Monitor System

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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