DEN180044 is an FDA 510(k) submission 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. (Alexandria, US). The FDA issued a Not Cleared (DENG) decision on September 11, 2018.
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 | DEN180044 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | August 14, 2018 |
| Decision Date | September 11, 2018 |
| Days to Decision | 28 days |
| Submission Type | Direct |
| Review Panel | Cardiovascular (CV) |
| Summary | - |
| 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. |