The following data is part of a premarket notification filed by Apple Inc. with the FDA for Ecg App.
| Device ID | K201525 |
| 510k Number | K201525 |
| Device Name: | ECG App |
| Classification | Electrocardiograph Software For Over-the-counter Use |
| Applicant | Apple Inc. One Apple Park Way Cupertino, CA 94015 |
| Contact | Luke Olson |
| Correspondent | Luke Olson Apple Inc. One Apple Park Way Cupertino, CA 94015 |
| Product Code | QDA |
| CFR Regulation Number | 870.2345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-08 |
| Decision Date | 2020-10-08 |