K201168 is an FDA 510(k) clearance for the ECG Monitor App. This device is classified as a Electrocardiograph Software For Over-the-counter Use (Class II — Special Controls, product code QDA).
Submitted by Samsung Electronics Co., Ltd. (Suwon-Si, KR). The FDA issued a Cleared decision on August 4, 2020, 95 days after receiving the submission on May 1, 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 | K201168 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 2020 |
| Decision Date | August 04, 2020 |
| Days to Decision | 95 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. |