Quick answer
FDA’s 510(k) database identifies K210753 for KardiaMobile 6L. The record gives the device classification and substantial-equivalence decision; it does not interpret readings for an individual.
FDA record summary
| Record field | FDA entry |
|---|---|
| 510(k) number | K210753 |
| Device name | KardiaMobile 6L |
| Classification name | Transmitters and receivers, electrocardiograph, telephone |
| Regulation number | 21 CFR 870.2920 |
| Product code | DXH, with subsequent codes listed by FDA |
| Decision date | June 30, 2021 |
| Decision | Substantially Equivalent (SESE) |
The record identifies a device submission from AliveCor. Read the linked FDA entry and summary for the complete regulatory description and scope.
Device record checklist
- Match the exact product name and generation to the FDA record.
- Review the summary’s stated intended use and device classification.
- Check the manufacturer’s current product documentation for phone and accessory compatibility.
- Keep regulatory record details separate from personal medical interpretation.
- Ask your doctor about ECG data, symptoms or a health decision.
For another ECG device record, read the Fitbit ECG App entry and Apple Watch ECG records. Browse ECG and heart devices.
Related guides
- Fitbit ECG App FDA 510(k) Record K200948
- Withings BPM Connect FDA Record: K223374
- Browse Heart & blood pressure.
Sources
Common questions
What does K210753 identify?
The FDA record names KardiaMobile 6L and lists a cardiovascular device classification.
What was the decision date?
The FDA database lists June 30, 2021, with a Substantially Equivalent decision.
Can a device record explain my ECG result?
No. For a reading, symptoms or care decision, speak with your doctor.