Electrocardiograph Software For Over-the-counter Use
Device Code: 990
Product Code(s):
QDA 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.
Device Classification Information
| Device Type ID | 990 |
| Device Name | Electrocardiograph Software For Over-the-counter Use |
| 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 |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.2345 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QDA |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 990 |
| Device | Electrocardiograph Software For Over-the-counter Use |
| Product Code | QDA |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 870.2345 [🔎] |
TPLC Last Update: 2019-04-02 19:45:56