K242935
- 510(k) number
- K242935
- Device name
- Respiration Data Management Software (PAP Link PC)
- Applicant
- BMC Medical Co., Ltd. CN
- Product code
- BZD — Ventilator, Non-Continuous (Respirator)
- Decision date
- 2025-01-15
- Date received
- 2024-09-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K242935.pdf
Official FDA record: K242935
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.