1 device · 1 company · 2025
Product code SDY: Loss Of Pulse Notification Software
1 device under product code SDY, 2025, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1 of 1 here), the regulation, and MAUDE report counts by product code.
Loss Of Pulse Notification Software. 21 CFR 870.2790, Class II. A photoplethysmograph analysis software device for over-the-counter use analyzes photoplethysmograph data and provides information for identifying loss of pulse. This device is not intended to provide a diagnosis. MAUDE held 0 adverse-event reports 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.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Loss of Pulse DetectionK242967 · 510(k) | Fitbit | Cardiovascular | database entry |
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