Automated Insulin Dosing , Threshold Suspend

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

Classification

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

Definition

An automated insulin dosing system that temporarily suspends or reduces insulin infusion from an insulin pump based upon specified thresholds of measured glucose levels.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 18

Source

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