FDA 510(k)

EYE-SYNC

K-Number: K152915 · 2016-01-29

Decision Date2016-01-29

Product CodeGWN

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

EYE-SYNC is the device name listed in this FDA 510(k) record. The listed applicant is Syncthink, Inc.. It received FDA 510(k) clearance on 2016-01-29 under 510(k) number K152915. The device is classified under product code GWN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EYE-SYNC?

EYE-SYNC is a medical device that received FDA 510(k) clearance on 2016-01-29. The listed applicant is Syncthink, Inc.. The 510(k) number is K152915.

When did EYE-SYNC receive FDA 510(k) clearance?

EYE-SYNC received FDA 510(k) clearance on 2016-01-29, under 510(k) number K152915.

Who is the listed applicant for EYE-SYNC?

The FDA 510(k) record lists Syncthink, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EYE-SYNC?

The FDA product code for EYE-SYNC is GWN.

Other records listing Syncthink, Inc. 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.

K202927EYE-SYNC

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.