FDA product code SDY

Loss Of Pulse Notification Software

Cardiovascular·Class 2·21 CFR 870.2790
US regulatory classifications
US Product Code (FDA)
SDY
View Product Code Classification →
US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 870.2790
View CFR Regulation →
Medical specialty
Cardiovascular
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

Search keywords
About this record

Loss Of Pulse Notification Software is a medical device type in the Cardiovascular specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.