FDA 510(k)

CUBEScan BioCon-1100

K-Number: K201995 · 2020-08-19

Decision Date2020-08-19

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CUBEScan BioCon-1100 is a medical device manufactured by Mcube Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-08-19 under approval number K201995. 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-1100?

CUBEScan BioCon-1100 is a medical device that received FDA 510(k) clearance on 2020-08-19. It is manufactured by Mcube Technology Co., Ltd.. The 510(k) number is K201995.

When was CUBEScan BioCon-1100 approved by the FDA?

CUBEScan BioCon-1100 received FDA 510(k) clearance on 2020-08-19, under approval number K201995.

What company makes CUBEScan BioCon-1100?

CUBEScan BioCon-1100 is manufactured by Mcube Technology Co., Ltd..

What is the FDA product code for CUBEScan BioCon-1100?

The FDA product code for CUBEScan BioCon-1100 is IYO.

Other Devices by Mcube Technology Co., Ltd.

K171591CUBEScan BioCon-900 (Bladder Volume Measurement System) K200749CUBEScan BioCon-900S K200548CUBEScan BioCon-1100

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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.