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Parker Quality & Compliance

PQC Reg Watch

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Device type

Automated Insulin Dosing Device System, Single Hormonal Control

Product code OZP · Class III · Unknown

An insulin-only automated insulin dosing system that achieves a target glucose level by automatically increasing or reducing insulin infusion from an insulin pump. Insulin adjustments are based upon specified thresholds of measured glucose levels.

FDA classification database

Recent 510(k)s

No 510(k) clearances in the archive for OZP.

Recent recalls