OmniPod Insulin Management System

Pump, Infusion, Insulin

INSULET CORPORATION

The following data is part of a premarket notification filed by Insulet Corporation with the FDA for Omnipod Insulin Management System.

Pre-market Notification Details

Device IDK162296
510k NumberK162296
Device Name:OmniPod Insulin Management System
ClassificationPump, Infusion, Insulin
Applicant INSULET CORPORATION 600 TECHNOLOGY PARK DRIVE SUITE 200 Billerica,  MA  01821
ContactMatthew King
CorrespondentMatthew King
INSULET CORPORATION 600 TECHNOLOGY PARK DRIVE SUITE 200 Billerica,  MA  01821
Product CodeLZG  
Subsequent Product CodeNBW
Subsequent Product CodeNDC
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-08-16
Decision Date2017-04-18
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.