Bigfoot Unity® Diabetes Management System
K-Number: K222280 · 2023-03-01
ApplicantBigfoot Biomedical, Inc.
Decision Date2023-03-01
Product CodeQLG
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
Bigfoot Unity® Diabetes Management System is a medical device manufactured by Bigfoot Biomedical, Inc.. It received FDA 510(k) clearance on 2023-03-01 under approval number K222280. The device is classified under product code QLG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Bigfoot Unity® Diabetes Management System?
Bigfoot Unity® Diabetes Management System is a medical device that received FDA 510(k) clearance on 2023-03-01. It is manufactured by Bigfoot Biomedical, Inc.. The 510(k) number is K222280.
When was Bigfoot Unity® Diabetes Management System approved by the FDA?
Bigfoot Unity® Diabetes Management System received FDA 510(k) clearance on 2023-03-01, under approval number K222280.
What company makes Bigfoot Unity® Diabetes Management System?
Bigfoot Unity® Diabetes Management System is manufactured by Bigfoot Biomedical, Inc..
What is the FDA product code for Bigfoot Unity® Diabetes Management System?
The FDA product code for Bigfoot Unity® Diabetes Management System is QLG.
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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.