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FDA 510(k)

Respiration Data Management Software (PAP Link PC)

K-Number: K242935 · 2025-01-15

ApplicantBMC Medical Co., Ltd.
Decision Date2025-01-15
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Respiration Data Management Software (PAP Link PC) is a medical device manufactured by BMC Medical Co., Ltd.. It received FDA 510(k) clearance on 2025-01-15 under approval number K242935. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Respiration Data Management Software (PAP Link PC)?

Respiration Data Management Software (PAP Link PC) is a medical device that received FDA 510(k) clearance on 2025-01-15. It is manufactured by BMC Medical Co., Ltd.. The 510(k) number is K242935.

When was Respiration Data Management Software (PAP Link PC) approved by the FDA?

Respiration Data Management Software (PAP Link PC) received FDA 510(k) clearance on 2025-01-15, under approval number K242935.

What company makes Respiration Data Management Software (PAP Link PC)?

Respiration Data Management Software (PAP Link PC) is manufactured by BMC Medical Co., Ltd..

What is the FDA product code for Respiration Data Management Software (PAP Link PC)?

The FDA product code for Respiration Data Management Software (PAP Link PC) is BZD.

Related Clinical Trials

NCT04910841 Feasibility of Using the "CGM GUARDIAN 2" Interstitial Fluid Glucose Measurement System in Intensive Care Medicine RECRUITING NCT07557147 Single-arm, Multi-center Study Evaluating the Acceptance and Feasibility of a Digital Remote Monitoring Tool Configured for Patients With ATTR-CM: ACO-Monitor NOT_YET_RECRUITING NCT07566728 ADAI - Home Care in Intelligent Environments Clinical Care Ecosystem for the Management of Home Digital Therapies Through the Use of Assistive Robots and Clinical Predictive Systems Based on Artificial Intelligence Systems COMPLETED NCT07384741 Using Virtual Reality During PICC and PICC-PORT Placement in Cancer Patients ACTIVE_NOT_RECRUITING NCT04969757 Use of Predigraft in Kidney Transplant Patients COMPLETED NCT07496346 Integration of a Robotic Platform for Clinical Monitoring of Patients With Severe Acquired Brain Injury in High-Intensity Care Units NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41938602 AI-enabled cardiovascular devices: a lifecycle playbook for evidence, change control, and post-market assurance. Frontiers in digital health (2026) PMID: 40409423 Navigating regulatory challenges across the life cycle of a SaMD. Journal of biomedical informatics (2025)

Other Devices by BMC Medical Co., Ltd.

K213169BPAP System K211155Auto CPAP System K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)

Related Devices (Code: BZD)

K160836Menai SystemResmed, Ltd. K161978AirFit N20Resmed, Ltd. K160127iCodeConnect3B Medical, Inc. K153505F&P Eson 2 Nasal MaskFisher & Paykel Healthcare Limited K160822S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASVResmed, Ltd. K153387Luna CPAP and Auto CPAP System3B Medical, Inc.

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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