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FDA 510(k)

EYE-SYNC

K-Number: K152915 · 2016-01-29

ApplicantSyncthink, Inc.
Decision Date2016-01-29
Product CodeGWN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EYE-SYNC is a medical device manufactured by Syncthink, Inc.. It received FDA 510(k) clearance on 2016-01-29 under approval 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. It is manufactured by Syncthink, Inc.. The 510(k) number is K152915.

When was EYE-SYNC approved by the FDA?

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

What company makes EYE-SYNC?

EYE-SYNC is manufactured by Syncthink, Inc..

What is the FDA product code for EYE-SYNC?

The FDA product code for EYE-SYNC is GWN.

Other Devices by Syncthink, Inc.

K202927EYE-SYNC

Related Devices (Code: GWN)

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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.

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