CUBEScan BioCon-900S
K-Number: K200749 · 2020-05-19
ApplicantMcube Technology Co., Ltd.
Decision Date2020-05-19
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
CUBEScan BioCon-900S is a medical device manufactured by Mcube Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-05-19 under approval number K200749. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CUBEScan BioCon-900S?
CUBEScan BioCon-900S is a medical device that received FDA 510(k) clearance on 2020-05-19. It is manufactured by Mcube Technology Co., Ltd.. The 510(k) number is K200749.
When was CUBEScan BioCon-900S approved by the FDA?
CUBEScan BioCon-900S received FDA 510(k) clearance on 2020-05-19, under approval number K200749.
What company makes CUBEScan BioCon-900S?
CUBEScan BioCon-900S is manufactured by Mcube Technology Co., Ltd..
What is the FDA product code for CUBEScan BioCon-900S?
The FDA product code for CUBEScan BioCon-900S is IYO.
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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.