| Device Type ID | 761 |
| Device Name | Electrode, Electrocardiograph |
| 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 | DRX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 761 |
| Device | Electrode, Electrocardiograph |
| Product Code | DRX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Electrocardiograph Electrode. |
| CFR Regulation Number | 870.2360 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
HMICRO, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Insufficient Information | 57 |
Adverse Event Without Identified Device Or Use Problem | 23 |
Improper Or Incorrect Procedure Or Method | 9 |
No Display / Image | 7 |
Appropriate Term/Code Not Available | 6 |
Missing Value Reason | 6 |
No Apparent Adverse Event | 3 |
Failure To Read Input Signal | 2 |
Unable To Obtain Readings | 2 |
Patient Device Interaction Problem | 2 |
Incorrect Interpretation Of Signal | 1 |
Device Handling Problem | 1 |
Detachment Of Device Component | 1 |
Device-Device Incompatibility | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Thermal Decomposition Of Device | 1 |
Gel Leak | 1 |
Failure To Adhere Or Bond | 1 |
Missing Information | 1 |
Sparking | 1 |
Device Operates Differently Than Expected | 1 |
Device Displays Incorrect Message | 1 |
| Total Device Problems | 129 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Leonhard Lang Medizintechnik GmbH | II | Nov-18-2015 |
| 2 | Leonhard Lang Medizintechnik GmbH | II | Mar-28-2015 |