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FDA 510(k)

EYE-SYNC

K-Number: K202927 · 2021-10-02

ApplicantSyncthink, Inc.
Decision Date2021-10-02
Product CodeQEA
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EYE-SYNC is a medical device manufactured by Syncthink, Inc.. It received FDA 510(k) clearance on 2021-10-02 under approval number K202927. The device is classified under product code QEA. 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 2021-10-02. It is manufactured by Syncthink, Inc.. The 510(k) number is K202927.

When was EYE-SYNC approved by the FDA?

EYE-SYNC received FDA 510(k) clearance on 2021-10-02, under approval number K202927.

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 QEA.

Other Devices by Syncthink, Inc.

K152915EYE-SYNC

Related Devices (Code: QEA)

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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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