FDA 510(k)

R2 Studio Q/RCT820

K-Number: K222219 · 2022-12-06

Decision Date2022-12-06

Product CodeOAS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

R2 Studio Q/RCT820 is a medical device manufactured by Megagen Implant Co., Ltd.. It received FDA 510(k) clearance on 2022-12-06 under approval number K222219. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the R2 Studio Q/RCT820?

R2 Studio Q/RCT820 is a medical device that received FDA 510(k) clearance on 2022-12-06. It is manufactured by Megagen Implant Co., Ltd.. The 510(k) number is K222219.

When was R2 Studio Q/RCT820 approved by the FDA?

R2 Studio Q/RCT820 received FDA 510(k) clearance on 2022-12-06, under approval number K222219.

What company makes R2 Studio Q/RCT820?

R2 Studio Q/RCT820 is manufactured by Megagen Implant Co., Ltd..

What is the FDA product code for R2 Studio Q/RCT820?

The FDA product code for R2 Studio Q/RCT820 is OAS.

Other Devices by Megagen Implant 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.