K232962
- 510(k) number
- K232962
- Device name
- Patient Monitor (iX10, iX12, iX15)
- Applicant
- Edan Instruments, Inc. CN
- Product code
- MHX — Monitor, Physiological, Patient(With Arrhythmia Dete
- Decision date
- 2024-04-19
- Date received
- 2023-09-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K232962.pdf
Official FDA record: K232962
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.