3 devices · 1 company · 2021 to 2023
Product code QDB: Photoplethysmograph Analysis Software For Over-The-Counter Use
3 devices under product code QDB, 2021 to 2023, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (3 of 3 here), the regulation, and MAUDE report counts by product code.
Photoplethysmograph Analysis Software For Over-The-Counter Use. 21 CFR 870.2790, Class II. 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. MAUDE held 1 adverse-event report against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
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| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Irregular Rhythm Notification FeatureK231173 · 510(k) | Apple Inc. | Cardiovascular | database entry | |
| Atrial Fibrillation History FeatureK213971 · 510(k) | Apple Inc. | Cardiovascular | database entry | |
| IRNF AppK212516 · 510(k) | Apple Inc. | Cardiovascular | database entry |
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