AHI System
K-Number: K212219 · 2021-12-03
ApplicantFifth Eye, Inc.
Decision Date2021-12-03
Product CodeQNV
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
AHI System is a medical device manufactured by Fifth Eye, Inc.. It received FDA 510(k) clearance on 2021-12-03 under approval number K212219. The device is classified under product code QNV. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the AHI System?
AHI System is a medical device that received FDA 510(k) clearance on 2021-12-03. It is manufactured by Fifth Eye, Inc.. The 510(k) number is K212219.
When was AHI System approved by the FDA?
AHI System received FDA 510(k) clearance on 2021-12-03, under approval number K212219.
What company makes AHI System?
AHI System is manufactured by Fifth Eye, Inc..
What is the FDA product code for AHI System?
The FDA product code for AHI System is QNV.
Other Devices by Fifth Eye, Inc.
Related Devices (Code: QNV)
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.