FDA 510(k)

1012WCC, 1012WGC

K-Number: K162518 · 2016-10-06

Decision Date2016-10-06

Product CodeMQB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

1012WCC, 1012WGC is a medical device manufactured by Rayence Co., Ltd.. It received FDA 510(k) clearance on 2016-10-06 under approval number K162518. 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 1012WCC, 1012WGC?

1012WCC, 1012WGC is a medical device that received FDA 510(k) clearance on 2016-10-06. It is manufactured by Rayence Co., Ltd.. The 510(k) number is K162518.

When was 1012WCC, 1012WGC approved by the FDA?

1012WCC, 1012WGC received FDA 510(k) clearance on 2016-10-06, under approval number K162518.

What company makes 1012WCC, 1012WGC?

1012WCC, 1012WGC is manufactured by Rayence Co., Ltd..

What is the FDA product code for 1012WCC, 1012WGC?

The FDA product code for 1012WCC, 1012WGC is MQB.

Other Devices by Rayence Co., Ltd.

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Related Devices (Code: MQB)

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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.