Bigfoot Unity Diabetes Management System
K-Number: K202145 · 2021-05-07
ApplicantBigfoot Biomedical, Inc.
Decision Date2021-05-07
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 2021-05-07 under approval number K202145. 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 2021-05-07. It is manufactured by Bigfoot Biomedical, Inc.. The 510(k) number is K202145.
When was Bigfoot Unity Diabetes Management System approved by the FDA?
Bigfoot Unity Diabetes Management System received FDA 510(k) clearance on 2021-05-07, under approval number K202145.
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
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