Definition: Devices Are Intended To Record And Analyze Single-lead Electrocardiograms. Devices Only Display Interval Values To The User. Devices Are Intended For Over-the-counter Sale. Devices Are Indicated For Users Who Wish To Monitor Common ECG Intervals.
| Device Type ID | 934 |
| Device Name | Single Lead Over-the-counter Electrocardiograph |
| Physical State | Battery-operated, Plastic Case, Metal Electrodes, Liquid Crystal Display |
| Technical Method | Records Single-lead Electrocardiogram Through Two Or Three Electrodes. Automatically Analyzes Waveform For Common, Clinically-accepted Intervals. |
| Target Area | Heart |
| Regulation Description | Electrocardiograph. |
| 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) |
| CFR Regulation Number | 870.2340 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OEY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
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| Device Type ID | 934 |
| Device | Single Lead Over-the-counter Electrocardiograph |
| Product Code | OEY |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Electrocardiograph. |
| CFR Regulation Number | 870.2340 [🔎] |