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FDA 510(k)

VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM

K-Number: K153548 · 2016-02-22

ApplicantVisionsense, Ltd.
Decision Date2016-02-22
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM is a medical device manufactured by Visionsense, Ltd.. It received FDA 510(k) clearance on 2016-02-22 under approval number K153548. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM?

VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM is a medical device that received FDA 510(k) clearance on 2016-02-22. It is manufactured by Visionsense, Ltd.. The 510(k) number is K153548.

When was VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM approved by the FDA?

VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM received FDA 510(k) clearance on 2016-02-22, under approval number K153548.

What company makes VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM?

VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM is manufactured by Visionsense, Ltd..

What is the FDA product code for VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM?

The FDA product code for VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM is HRX.

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Other Devices by Visionsense, Ltd.

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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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