Omnipod Insulin Management System, Omnipod DASH Insulin Management System
K-Number: K192659 · 2019-10-21
ApplicantInsulet Corporation
Decision Date2019-10-21
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 2019-10-21 under approval number K192659. 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 2019-10-21. It is manufactured by Insulet Corporation. The 510(k) number is K192659.
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 2019-10-21, under approval number K192659.
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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Other Devices by Insulet Corporation
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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.