OmniPod Insulin Management System
K-Number: K160252 · 2016-04-27
ApplicantInsulet Corporation
Decision Date2016-04-27
Product CodeLZG
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
OmniPod Insulin Management System is a medical device manufactured by Insulet Corporation. It received FDA 510(k) clearance on 2016-04-27 under approval number K160252. The device is classified under product code LZG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the OmniPod Insulin Management System?
OmniPod Insulin Management System is a medical device that received FDA 510(k) clearance on 2016-04-27. It is manufactured by Insulet Corporation. The 510(k) number is K160252.
When was OmniPod Insulin Management System approved by the FDA?
OmniPod Insulin Management System received FDA 510(k) clearance on 2016-04-27, under approval number K160252.
What company makes OmniPod Insulin Management System?
OmniPod Insulin Management System is manufactured by Insulet Corporation.
What is the FDA product code for OmniPod Insulin Management System?
The FDA product code for OmniPod Insulin Management System is LZG.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.