SmartAdjust technology
K-Number: K203774 · 2022-01-27
ApplicantInsulet Corporation
Decision Date2022-01-27
Product CodeQJI
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
SmartAdjust technology is a medical device manufactured by Insulet Corporation. It received FDA 510(k) clearance on 2022-01-27 under approval number K203774. The device is classified under product code QJI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SmartAdjust technology?
SmartAdjust technology 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 K203774.
When was SmartAdjust technology approved by the FDA?
SmartAdjust technology received FDA 510(k) clearance on 2022-01-27, under approval number K203774.
What company makes SmartAdjust technology?
SmartAdjust technology is manufactured by Insulet Corporation.
What is the FDA product code for SmartAdjust technology?
The FDA product code for SmartAdjust technology is QJI.
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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.