K201525 is an FDA 510(k) clearance for the ECG App. This device is classified as a Electrocardiograph Software For Over-the-counter Use (Class II - Special Controls, product code QDA).
Submitted by Apple, Inc. (Cupertino, US). The FDA issued a Cleared decision on October 8, 2020, 122 days after receiving the submission on June 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 | K201525 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 08, 2020 |
| Decision Date | October 08, 2020 |
| Days to Decision | 122 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. |