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FDA PRODUCT CODE · CLASS III

OZQ — Automated Insulin Dosing Device System, Bihormonal Control

A bihormonal automated insulin dosing system that achieves a target glucose level by automatically adjusting two glucose modulating therapies from an infusion pump. Hormone adjustments are based upon specified thresholds of measured glucose levels.

DEVICE CLASS
Class III
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
CH
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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