K250179
- 510(k) number
- K250179
- Device name
- Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)
- Applicant
- Edan Instruments, Inc. CN
- Product code
- MHX — Monitor, Physiological, Patient(With Arrhythmia Dete
- Decision date
- 2025-07-29
- Date received
- 2025-01-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.5 MB · U.S. public domain
Also available from FDA: K250179.pdf
Official FDA record: K250179
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.