QDAClass II
Electrocardiograph Software For Over-The-Counter Use
21 CFR 870.2345 / Cardiovascular
QDA is the FDA product code for Electrocardiograph Software For Over-The-Counter Use, a class II device type, regulated under 21 CFR 870.2345. FDA's definition for this code reads: "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". As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QDA
- Device name
- Electrocardiograph Software For Over-The-Counter Use
- FDA 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.
- Regulation
- 21 CFR 870.2345
- Device class
- Class II
- Review panel
- Cardiovascular
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 9
- Ingested recalls
- 0
Clearances, product code QDA
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2018 | 1 |
| 2020 | 3 |
| 2023 | 2 |
| 2024 | 1 |
| 2025 | 2 |
Applicants with the most clearances
Product code QDA| Applicant | Clearances |
|---|---|
| Samsung Electronics Co., Ltd. | 3 |
| Apple, Inc. | 1 |
| Apple Inc. | 1 |
| Fitbit LLC | 1 |
| Garmin International, Inc. | 1 |
| Whoop, Inc. | 1 |
| Withings | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.