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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Mcube Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-05-19 under 510(k) 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. The listed applicant is Mcube Technology Co., Ltd.. The 510(k) number is K200749.

When did CUBEScan BioCon-900S receive FDA 510(k) clearance?

CUBEScan BioCon-900S received FDA 510(k) clearance on 2020-05-19, under 510(k) number K200749.

Who is the listed applicant for CUBEScan BioCon-900S?

The FDA 510(k) record lists Mcube Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CUBEScan BioCon-900S?

The FDA product code for CUBEScan BioCon-900S is IYO.

Other records listing Mcube Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K201995CUBEScan BioCon-1100K200548CUBEScan BioCon-1100K171591CUBEScan™ BioCon-900 (Bladder Volume Measurement System)

Related Devices (Code: IYO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.K253714IntraSight PlusPhilips Image Guided Therapy Corporation

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.

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