Electrocardiograph Software For Over-The-Counter Use
The Electrocardiograph Software For Over-The-Counter Use is a software device that creates, analyzes, and displays electrocardiograph data and can provide information for identifying cardiac arrhythmias; it is not intended to provide a diagnosis and is available without a prescription. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is QDA under regulation 870.2345 in the Cardiovascular specialty. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QDA
- Device Class
- FDA class 2
- Regulation Number
- 870.2345
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K240795 | Withings ECG App | Jun 15, 2025 | Substantially Equivalent | Withings |
| K243236 | WHOOP ECG (electrocardiogram) Feature (1.0) | Apr 04, 2025 | Substantially Equivalent | Whoop., Inc. |
| K240909 | Samsung ECG App v 1.3 (ECG) | Aug 02, 2024 | Substantially Equivalent | Samsung Electronics Co., Ltd. |
| K230292 | Samsung ECG Monitor Application with Irregular Heart Rhythm Notification | May 02, 2023 | Substantially Equivalent | Samsung Electronics Co., Ltd. |
| K221774 | Garmin ECG App | Jan 12, 2023 | Substantially Equivalent | Garmin International, Inc. |
| K201525 | ECG App | Oct 08, 2020 | Substantially Equivalent | Apple, Inc. |
| K200948 | Fitbit ECG App | Sep 11, 2020 | Substantially Equivalent | Fitbit, Inc. |
| K201168 | ECG Monitor App | Aug 04, 2020 | Substantially Equivalent | Samsung Electronics Co., Ltd. |
| DEN180044 | ECG App | Sep 11, 2018 | Unknown | Apple, Inc. |
FEI Numbers
This FDA classification entry is associated with 18 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 18 registration numbers. Click on an entry to view related FDA registrations.