| Device Type ID | 880 |
| Device Name | Electrode, Electrocardiograph, Multi-function |
| Regulation Description | Electrocardiograph Electrode. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Cardiac Diagnostics Devices Branch (CDDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 870.2360 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MLN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 880 |
| Device | Electrode, Electrocardiograph, Multi-function |
| Product Code | MLN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Electrocardiograph Electrode. |
| CFR Regulation Number | 870.2360 [🔎] |
| Device Problems | |
|---|---|
Gel Leak | 8 |
Device Operates Differently Than Expected | 8 |
Connection Problem | 8 |
Device Sensing Problem | 5 |
Adverse Event Without Identified Device Or Use Problem | 4 |
Failure To Sense | 3 |
Bent | 2 |
Fire | 2 |
Failure To Read Input Signal | 2 |
Material Separation | 2 |
Incomplete Or Missing Packaging | 1 |
Device Handling Problem | 1 |
Failure To Deliver Energy | 1 |
Failure Of Device To Self-Test | 1 |
Incomplete Or Inadequate Connection | 1 |
Difficult To Open Or Remove Packaging Material | 1 |
Failure To Discharge | 1 |
Connector | 1 |
Thermal Decomposition Of Device | 1 |
Defibrillation Problem | 1 |
Device Inoperable | 1 |
Material Integrity Problem | 1 |
Misconnection | 1 |
Device Displays Incorrect Message | 1 |
Signal Artifact | 1 |
Use Of Device Problem | 1 |
Delamination | 1 |
| Total Device Problems | 61 |