510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
OZQClass III

Automated Insulin Dosing Device System, Bihormonal Control

Unknown
FDA source (opens on fda.gov)

OZQ is the FDA product code for Automated Insulin Dosing Device System, Bihormonal Control, a class III device type. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
OZQ
Device name
Automated Insulin Dosing Device System, Bihormonal Control
FDA definition
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
Review panel
Unknown
Submission type
PMA
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code OZQ.