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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 the device name listed in this FDA 510(k) record. The listed applicant is Visionsense, Ltd.. It received FDA 510(k) clearance on 2016-02-22 under 510(k) 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. The listed applicant is Visionsense, Ltd.. The 510(k) number is K153548.

When did VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM receive FDA 510(k) clearance?

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

Who is the listed applicant for VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM?

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

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.

Other records listing Visionsense, Ltd. 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.

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Related Devices (Code: HRX)

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.

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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.

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