Omnipod 5 SmartBolus Calculator
K-Number: K203772 · 2022-01-27
ApplicantInsulet Corporation
Decision Date2022-01-27
Product CodeQRX
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
Omnipod 5 SmartBolus Calculator is a medical device manufactured by Insulet Corporation. It received FDA 510(k) clearance on 2022-01-27 under approval number K203772. The device is classified under product code QRX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Omnipod 5 SmartBolus Calculator?
Omnipod 5 SmartBolus Calculator is a medical device that received FDA 510(k) clearance on 2022-01-27. It is manufactured by Insulet Corporation. The 510(k) number is K203772.
When was Omnipod 5 SmartBolus Calculator approved by the FDA?
Omnipod 5 SmartBolus Calculator received FDA 510(k) clearance on 2022-01-27, under approval number K203772.
What company makes Omnipod 5 SmartBolus Calculator?
Omnipod 5 SmartBolus Calculator is manufactured by Insulet Corporation.
What is the FDA product code for Omnipod 5 SmartBolus Calculator?
The FDA product code for Omnipod 5 SmartBolus Calculator is QRX.
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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.