510(k) K113653 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
PATIENT MONITOR
| Applicant | Edan Instruments, Inc., Shenzhen, CN |
| Decision | Substantially Equivalent, Feb 6, 2012 |
| Received | Dec 12, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113653
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 22, 2026 | Edan Diagnostics Brand Name: EDAN
Product Name: Patient Monitor
Model/Catalog Number: iM8, iM8A, iM8B
Product Description: iM8 Series Patient Monitor can perform long-time continuous monitoring of multiple physiologic Open, Classified |
MHX | None listed |
| Jun 23, 2016 | Edan Diagnostics EtCO2 Module -Part Number: 02.01.210699 Monitors: iM80, iM50, M50, iM70, iM60, iM8, iM8A, iM8B Patient Monitors and iM60 Vet, iM70 Vet Veterinary Monitors
EtCO2 module is an optional component of the Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.