FDA 510(k)

AEYE-DS

K-Number: K221183 · 2022-11-10

Decision Date2022-11-10

Product CodePIB

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

AEYE-DS is the device name listed in this FDA 510(k) record. The listed applicant is Aeye Health, Inc.. It received FDA 510(k) clearance on 2022-11-10 under 510(k) number K221183. The device is classified under product code PIB. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AEYE-DS?

AEYE-DS is a medical device that received FDA 510(k) clearance on 2022-11-10. The listed applicant is Aeye Health, Inc.. The 510(k) number is K221183.

When did AEYE-DS receive FDA 510(k) clearance?

AEYE-DS received FDA 510(k) clearance on 2022-11-10, under 510(k) number K221183.

Who is the listed applicant for AEYE-DS?

The FDA 510(k) record lists Aeye Health, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AEYE-DS?

The FDA product code for AEYE-DS is PIB.

Other records listing Aeye Health, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240058AEYE-DS

Related Devices (Code: PIB)

K253704iPredict-DRiHealthscreen, Inc.K240058AEYE-DSAeye Health, Inc.K223357EyeArt v2.2.0Eyenuk, Inc.K213037IDx-DR v2.3Digital Diagnostics, Inc.K203629IDx-DRDigital Diagnostics, Inc.K200667EyeArtEyenuk, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.