K200948 is an FDA 510(k) clearance for the Fitbit ECG App. This device is classified as a Electrocardiograph Software For Over-the-counter Use (Class II - Special Controls, product code QDA).
Submitted by Fitbit, Inc. (San Francisco, US). The FDA issued a Cleared decision on September 11, 2020, 156 days after receiving the submission on April 8, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2345. 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..
| 510(k) Number | K200948 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 08, 2020 |
| Decision Date | September 11, 2020 |
| Days to Decision | 156 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | QDA - Electrocardiograph Software For Over-the-counter Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2345 |
| 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. |