G-EYE System
K-Number: K202469 · 2020-10-26
ApplicantSmart Medical Systems , Ltd.
Decision Date2020-10-26
Product CodeFDF
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
G-EYE System is a medical device manufactured by Smart Medical Systems , Ltd.. It received FDA 510(k) clearance on 2020-10-26 under approval number K202469. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the G-EYE System?
G-EYE System is a medical device that received FDA 510(k) clearance on 2020-10-26. It is manufactured by Smart Medical Systems , Ltd.. The 510(k) number is K202469.
When was G-EYE System approved by the FDA?
G-EYE System received FDA 510(k) clearance on 2020-10-26, under approval number K202469.
What company makes G-EYE System?
G-EYE System is manufactured by Smart Medical Systems , Ltd..
What is the FDA product code for G-EYE System?
The FDA product code for G-EYE System is FDF.
Other Devices by Smart Medical Systems , Ltd.
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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.