Respiration Data Management Software (PAP Link PC)
BMC Medical Co., Ltd.The Respiration Data Management Software is a healthcare application installed on a computer that helps clinicians monitor and manage respiratory therapy treatment data from compatible CPAP and BPAP devices. It allows viewing treatment data, generating reports, and remotely adjusting therapy device settings to assist in patient care within healthcare facilities safely and efficiently.
Intended Use
Respiration Data Management Software is installed in a computer to perform patient management by treatment data viewing, treatment data reporting and remotely adjusting the prescribed compatible BMC CPAP and BPAP devices' settings. It is intended for healthcare professionals in healthcare facilities use only.
Technology
Software-only device that allows transmission, analysis, review, and remote adjustment of respiratory therapy data from compatible CPAP and BPAP devices. It can store patient data, upload data to a cloud platform, generate and print reports, and supports wireless communication and software updates.
Performance
Software verification and validation were performed according to FDA guidance for device software functions. Cybersecurity evaluation and testing were also conducted following FDA guidance to ensure safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/25/2024
3 months - 2
FDA Approval
1/15/2025
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