Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

E>EyeC

K-Number: K200616 · 2020-06-11

ApplicantE-Swin
Decision Date2020-06-11
Product CodeONF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

E>EyeC is a medical device manufactured by E-Swin. It received FDA 510(k) clearance on 2020-06-11 under approval number K200616. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the E>EyeC?

E>EyeC is a medical device that received FDA 510(k) clearance on 2020-06-11. It is manufactured by E-Swin. The 510(k) number is K200616.

When was E>EyeC approved by the FDA?

E>EyeC received FDA 510(k) clearance on 2020-06-11, under approval number K200616.

What company makes E>EyeC?

E>EyeC is manufactured by E-Swin.

What is the FDA product code for E>EyeC?

The FDA product code for E>EyeC is ONF.

Related Devices (Code: ONF)

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.