Name: Predicase
Price: 199 USD

K-number	K211575
Device name	Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System
Applicant	Insulet Corporation
Product code	LZG
Device class	Class II
Decision date	Aug 13, 2021
Decision	Substantially Equivalent
Regulation	880.5725

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Source

View the full FDA submission: accessdata.fda.gov

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Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System

Everything you need for a 510(k) submission. Nothing you don't.