Computer-Assisted Personalized Sedation System

PDR · Class III — High Risk (PMA approval required, life-sustaining) · Unknown

Classification

FDA Product Code: PDR
Device class: Class III — High Risk (PMA approval required, life-sustaining)
Regulation: —
Review panel: AN
Medical specialty: Unknown
Submission type: 2
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 0

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown