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
OZPClass III

Automated Insulin Dosing Device System, Single Hormonal Control

Unknown
FDA source (opens on fda.gov)

OZP is the FDA product code for Automated Insulin Dosing Device System, Single Hormonal Control, a class III device type. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and 23 recalls.

Classification record

Product code
OZP
Device name
Automated Insulin Dosing Device System, Single Hormonal Control
FDA definition
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.
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
23

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 15 companies shown, in name order