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FDA 510(k)

Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)

K-Number: K240271 · 2024-09-11

ApplicantLinshom Medical, Inc.
Decision Date2024-09-11
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) is a medical device manufactured by Linshom Medical, Inc.. It received FDA 510(k) clearance on 2024-09-11 under approval number K240271. 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 Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)?

Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) is a medical device that received FDA 510(k) clearance on 2024-09-11. It is manufactured by Linshom Medical, Inc.. The 510(k) number is K240271.

When was Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) approved by the FDA?

Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) received FDA 510(k) clearance on 2024-09-11, under approval number K240271.

What company makes Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)?

Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) is manufactured by Linshom Medical, Inc..

What is the FDA product code for Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)?

The FDA product code for Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) is BZQ.

Related Clinical Trials

NCT07614139 Continuous Glucose Monitoring Alerts, Accuracy, and Patient Outcomes in Adults With Inherited Metabolic Disorders COMPLETED NCT07599982 Safety Evaluation of MODI, an Insulin Titration Algorithm, in Adults With Diabetes RECRUITING NCT07092761 Evaluation of the Accuracy and Safety of A Novel Real-Time Continuous Glucose Monitoring System RECRUITING NCT07499128 Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event ENROLLING_BY_INVITATION NCT07606495 Impact on Prognosis of Increased Sleep Quality Obtained by Personalized Night-time Nursing Care in Critically Ill Patients NOT_YET_RECRUITING NCT07614581 Intra-Sessional Autonomic Arc Detection in Ketamine-Assisted Therapy for PTSD: A Signal Characterisation Pilot Study NOT_YET_RECRUITING

Related PubMed Literature

PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 41964171 Journal of diabetes science and technology (2026) PMID: 41760572 Trends in use of continuous glucose monitors among individuals with type 2 diabetes enrolled in Medicare Advantage (2021-2023). Journal of managed care & specialty pharmacy (2026)

Other Devices by Linshom Medical, Inc.

K250093Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)

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

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