510(k) K161056 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Telemetry Transmitter
| Applicant | Edan Instruments, Inc., Shenzhen, CN |
| Decision | Substantially Equivalent, Feb 3, 2017 |
| Received | Apr 14, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161056
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 22, 2026 | Edan Diagnostics Brand Name: EDAN
Product Name: Telemetry Transmitter
Model/Catalog Number: iT20
Product Description: iT20 collects physiological parameters by ECG cables and SpO2 sensors, then achieves data analyzing Open, Classified |
MHX | None listed |
| Feb 18, 2020 | Edan Diagnostics EDAN Telemetry Transmitter, Model iT20 - Product Usage: The iT20 telemetry transmitter is intended to be used in clinical divisions of hospital environments, including CCU and general wards (as Cardio Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.