SDY

Loss Of Pulse Notification Software

Product code

SDY

Device name

Loss Of Pulse Notification Software

Device class

Class 2

21 CFR

21 CFR 870.2790

Medical specialty

Cardiovascular

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-02-25.

1 summaries are archived here for direct download.