Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Respiree Cardio- Respiratory Monitor System

K-Number: K250934 · 2025-08-05

ApplicantRespiree Pte, Ltd.
Decision Date2025-08-05
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Respiree Cardio- Respiratory Monitor System is a medical device manufactured by Respiree Pte, Ltd.. It received FDA 510(k) clearance on 2025-08-05 under approval number K250934. 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 System?

Respiree Cardio- Respiratory Monitor System is a medical device that received FDA 510(k) clearance on 2025-08-05. It is manufactured by Respiree Pte, Ltd.. The 510(k) number is K250934.

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

Respiree Cardio- Respiratory Monitor System received FDA 510(k) clearance on 2025-08-05, under approval number K250934.

What company makes Respiree Cardio- Respiratory Monitor System?

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

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

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

Related Clinical Trials

NCT05452226 Neuromuscular Electrical Stimulation in COPD/Community Acquired Pneumonia COMPLETED NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT03331380 Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System RECRUITING NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED NCT07611721 Evaluate the Performance of the Dexcom G7 Continuous Glucose Monitoring (CGM) System in Critically Ill Patients Undergoing Major Abdominal Surgery and Solid Organ Transplantation Which Require Blood Glucose Monitoring for Intensive Insulin Therapy. RECRUITING NCT06385392 Continuous Wearable Monitor for the Detection and Release of Freezing of Gait. COMPLETED

Other Devices by Respiree Pte, Ltd.

K223681Respiree Cardio-Respiratory Monitor

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.

↑