Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System
K-Number: K211575 · 2021-08-13
ApplicantInsulet Corporation
Decision Date2021-08-13
Product CodeLZG
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System is a medical device manufactured by Insulet Corporation. It received FDA 510(k) clearance on 2021-08-13 under approval number K211575. 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 DASH® Insulin Management System?
Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System is a medical device that received FDA 510(k) clearance on 2021-08-13. It is manufactured by Insulet Corporation. The 510(k) number is K211575.
When was Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System approved by the FDA?
Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System received FDA 510(k) clearance on 2021-08-13, under approval number K211575.
What company makes Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System?
Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System is manufactured by Insulet Corporation.
What is the FDA product code for Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System?
The FDA product code for Omnipod® Insulin Management System, Omnipod DASH® 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.