SmartBolus Calculator
K-Number: K222239 · 2022-08-19
ApplicantInsulet Corporation
Decision Date2022-08-19
Product CodeQRX
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
SmartBolus Calculator is a medical device manufactured by Insulet Corporation. It received FDA 510(k) clearance on 2022-08-19 under approval number K222239. 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 SmartBolus Calculator?
SmartBolus Calculator is a medical device that received FDA 510(k) clearance on 2022-08-19. It is manufactured by Insulet Corporation. The 510(k) number is K222239.
When was SmartBolus Calculator approved by the FDA?
SmartBolus Calculator received FDA 510(k) clearance on 2022-08-19, under approval number K222239.
What company makes SmartBolus Calculator?
SmartBolus Calculator is manufactured by Insulet Corporation.
What is the FDA product code for SmartBolus Calculator?
The FDA product code for 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.