AEYE-DS
K-Number: K240058 · 2024-04-23
ApplicantAeye Health, Inc.
Decision Date2024-04-23
Product CodePIB
Advisory CommitteeOP
DecisionSubstantially Equivalent
Device Summary
AEYE-DS is a medical device manufactured by Aeye Health, Inc.. It received FDA 510(k) clearance on 2024-04-23 under approval number K240058. 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 2024-04-23. It is manufactured by Aeye Health, Inc.. The 510(k) number is K240058.
When was AEYE-DS approved by the FDA?
AEYE-DS received FDA 510(k) clearance on 2024-04-23, under approval number K240058.
What company makes AEYE-DS?
AEYE-DS is manufactured by Aeye Health, Inc..
What is the FDA product code for AEYE-DS?
The FDA product code for AEYE-DS is PIB.
Other Devices by Aeye Health, Inc.
Related Devices (Code: PIB)
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.