FDA’s 510(k) database identifies K200948 as a record for the Fitbit ECG App. The record names an over-the-counter electrocardiograph software classification and a substantial-equivalence decision.
FDA record summary
| Record field | FDA entry |
|---|---|
| 510(k) number | K200948 |
| Device name | Fitbit ECG App |
| Classification name | Electrocardiograph software for over-the-counter use |
| Regulation number | 21 CFR 870.2345 |
| Decision date | September 11, 2020 |
| Decision | Substantially Equivalent (SESE) |
These fields come from the FDA’s searchable 510(k) record. The database entry identifies a regulatory submission and decision; it is not a personal interpretation of an ECG or a diagnosis.
Match a product to the entry
- Find the model and app name in the device maker’s current documentation.
- Confirm that the record names the same device and intended function.
- Read the FDA summary for the stated scope and limitations.
- Keep software and wearable model details together when checking compatibility.
- For symptoms, test results or care decisions, speak with your doctor.
Compare Fitbit ECG with a handheld ECG product and read what FDA records say about Apple Watch ECG. Browse ECG and heart devices.
Related guides
- KardiaMobile 6L FDA 510(k) Record K210753
- Withings BPM Connect FDA Record: K223374
- Browse Heart & blood pressure.
Sources
Common questions
What does the FDA record call the device?
It lists the device name as Fitbit ECG App and classification name as electrocardiograph software for over-the-counter use.
What is the K number?
The FDA 510(k) record is K200948, with a decision date of September 11, 2020.
Does this record diagnose a heart condition?
The record is a regulatory entry, not individual medical guidance. Ask your doctor about results or health concerns.