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FDA 510(k)

AHI System

K-Number: K221203 · 2022-07-14

ApplicantFifth Eye, Inc.
Decision Date2022-07-14
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 2022-07-14 under approval number K221203. 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 2022-07-14. It is manufactured by Fifth Eye, Inc.. The 510(k) number is K221203.

When was AHI System approved by the FDA?

AHI System received FDA 510(k) clearance on 2022-07-14, under approval number K221203.

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.

K212219AHI System DEN200022Analytic for Hemodynamic Instability (AHI)

Related Devices (Code: QNV)

K212219AHI SystemFifth Eye, Inc. DEN200022Analytic for Hemodynamic Instability (AHI)Fifth Eye, Inc.

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.

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