FDA 510(k)

1212FCA

K-Number: K202722 · 2020-10-26

Decision Date2020-10-26

Product CodeMQB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

1212FCA is a medical device manufactured by Rayence Co., Ltd.. It received FDA 510(k) clearance on 2020-10-26 under approval number K202722. 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 1212FCA?

1212FCA is a medical device that received FDA 510(k) clearance on 2020-10-26. It is manufactured by Rayence Co., Ltd.. The 510(k) number is K202722.

When was 1212FCA approved by the FDA?

1212FCA received FDA 510(k) clearance on 2020-10-26, under approval number K202722.

What company makes 1212FCA?

1212FCA is manufactured by Rayence Co., Ltd..

What is the FDA product code for 1212FCA?

The FDA product code for 1212FCA is MQB.

Other Devices by Rayence Co., 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.