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FDA 510(k)

VIVIX-S 1012N

K-Number: K152855 · 2016-02-26

ApplicantVieworks Co., Ltd.
Decision Date2016-02-26
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VIVIX-S 1012N is a medical device manufactured by Vieworks Co., Ltd.. It received FDA 510(k) clearance on 2016-02-26 under approval number K152855. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIVIX-S 1012N?

VIVIX-S 1012N is a medical device that received FDA 510(k) clearance on 2016-02-26. It is manufactured by Vieworks Co., Ltd.. The 510(k) number is K152855.

When was VIVIX-S 1012N approved by the FDA?

VIVIX-S 1012N received FDA 510(k) clearance on 2016-02-26, under approval number K152855.

What company makes VIVIX-S 1012N?

VIVIX-S 1012N is manufactured by Vieworks Co., Ltd..

What is the FDA product code for VIVIX-S 1012N?

The FDA product code for VIVIX-S 1012N is MQB.

Other Devices by Vieworks Co., Ltd.

K161113QXLink K152894VIVIX-S 1717N K163703VIVIX-S 1417N K181003VIVIX-S 1717V K190611VIVIX-S 1751S K200418VIVIX-S VW

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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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