K251508
- 510(k) number
- K251508
- Device name
- Telemetry Monitor (iT30, iT50)
- Applicant
- Edan Instruments, Inc. CN
- Product code
- MHX — Monitor, Physiological, Patient(With Arrhythmia Dete
- Decision date
- 2026-08-06
- Date received
- 2025-05-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K251508.pdf
Official FDA record: K251508
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.