PDR

Computer-Assisted Personalized Sedation System

Product code: PDR
Device name: Computer-Assisted Personalized Sedation System
Device class: Class 3
Medical specialty: Unknown
Marketing pathway: PMA

FDA classification definition

Computer assisted system to administer a drug and control depth of sedation and provide monitoring and alarms for physiological vital signs and other parameters of sedation.

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

Official FDA classification page: PDR

Classification and pathway per current FDA publications. Data from openFDA (CC0).