FDA 510(k)

0909FCB, 1212FCA

K-Number: K212753 · 2021-10-18

Decision Date2021-10-18

Product CodeMQB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

0909FCB, 1212FCA is a medical device manufactured by Rayence Co., Ltd.. It received FDA 510(k) clearance on 2021-10-18 under approval number K212753. 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 0909FCB, 1212FCA?

0909FCB, 1212FCA is a medical device that received FDA 510(k) clearance on 2021-10-18. It is manufactured by Rayence Co., Ltd.. The 510(k) number is K212753.

When was 0909FCB, 1212FCA approved by the FDA?

0909FCB, 1212FCA received FDA 510(k) clearance on 2021-10-18, under approval number K212753.

What company makes 0909FCB, 1212FCA?

0909FCB, 1212FCA is manufactured by Rayence Co., Ltd..

What is the FDA product code for 0909FCB, 1212FCA?

The FDA product code for 0909FCB, 1212FCA is 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.