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 the device name listed in this FDA 510(k) record. The listed applicant is E-Swin. It received FDA 510(k) clearance on 2020-06-11 under 510(k) 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. The listed applicant is E-Swin. The 510(k) number is K200616.
When did E>EyeC receive FDA 510(k) clearance?
E>EyeC received FDA 510(k) clearance on 2020-06-11, under 510(k) number K200616.
Who is the listed applicant for E>EyeC?
The FDA 510(k) record lists E-Swin as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for E>EyeC?
The FDA product code for E>EyeC is ONF.
Related Devices (Code: ONF)
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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.