| Device |
electrocardiograph software for over-the-counter use |
| Regulation Description |
Electrocardiograph software for over-the-counter use. |
| Definition |
An electrocardiograph software device for over-the-counter use creates, analyzes, and displays electrocardiograph data, and can provide information for identifying cardiac arrhythmias. This device is not intended to provide a diagnosis. |
| Physical State |
The devices uses consumer grade electronics and is hand held or worn on the wrist, arms, or chest. |
| Technical Method |
Uses input from leads attached to or in contact with the users hands, wrists, arms, or chest to detect potential differences and generate an ECG waveform. |
| Target Area |
Hands, arms, or chest. |
| Regulation Medical Specialty |
Cardiovascular |
| Review Panel |
Cardiovascular |
|---|
| Product Code | QDA |
|---|
| Premarket Review |
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices
(DHT2A)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices
(DHT2A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
870.2345
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
|
|
