PDR — Computer-Assisted Personalized Sedation System Class III
FDA product code PDR covers "Computer-Assisted Personalized Sedation System", a Class III medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- PDR
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Unknown
- Implant
- No
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.