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
OZOClass III

Automated Insulin Dosing , Threshold Suspend

Unknown
FDA source (opens on fda.gov)

OZO is the FDA product code for Automated Insulin Dosing , Threshold Suspend, a class III device type. FDA's definition for this code reads: "An automated insulin dosing system that temporarily suspends or reduces insulin infusion from an insulin pump based upon specified thresholds of measured glucose levels". As of , FDA records hold no 510(k) clearances under this code and 11 recalls.

Classification record

Product code
OZO
Device name
Automated Insulin Dosing , Threshold Suspend
FDA 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.
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
11

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 15 companies shown, in name order