Atrial Fibrillation History Feature
FDA 510(k) K213971 · Apple, Inc.
510(k) numberK213971
Submission
- Device name
- Atrial Fibrillation History Feature
- Applicant
- Apple, Inc.
Cupertino, CA, US - Received
- December 20, 2021
- Decision date
- June 3, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QDB – Photoplethysmograph Analysis Software For Over-The-Counter Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2790
- Specialty
- Cardiovascular
A photoplethysmograph analysis software device for over-the-counter use analyzes photoplethysmograph data and provides information for identifying irregular heart rhythms. This device is not intended to provide a diagnosis.
Other 510(k)s with product code QDB
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| K212516 | IRNF AppQDB · Traditional | 10/22/2021SE |
| K201525 | ECG AppQDA · Traditional | 10/08/2020SE |
Questions and answers
When was Atrial Fibrillation History Feature cleared by the FDA?
Atrial Fibrillation History Feature (K213971) received a 510(k) decision of Substantially Equivalent on June 3, 2022, 165 days after the submission was received.
What is the product code of K213971?
The FDA product code is QDB – Photoplethysmograph Analysis Software For Over-The-Counter Use, a Class II (moderate risk) device regulated under 21 CFR 870.2790.