G-EYE System
K-Number: K192588 · 2020-04-15
Device Summary
Frequently Asked Questions
What is the G-EYE System?
G-EYE System is a medical device that received FDA 510(k) clearance on 2020-04-15. The listed applicant is Smart Medical Systems , Ltd.. The 510(k) number is K192588.
When did G-EYE System receive FDA 510(k) clearance?
G-EYE System received FDA 510(k) clearance on 2020-04-15, under 510(k) number K192588.
Who is the listed applicant for G-EYE System?
The FDA 510(k) record lists Smart Medical Systems , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for G-EYE System?
The FDA product code for G-EYE System is FDF.
Other records listing Smart Medical Systems , Ltd. 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.
Related Devices (Code: FDF)
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.
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.