FDA 510(k)

MINAMO

K-Number: K190176 · 2019-08-01

Decision Date2019-08-01

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MINAMO is a medical device manufactured by Asahi Intecc Co., Ltd.. It received FDA 510(k) clearance on 2019-08-01 under approval number K190176. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MINAMO?

MINAMO is a medical device that received FDA 510(k) clearance on 2019-08-01. It is manufactured by Asahi Intecc Co., Ltd.. The 510(k) number is K190176.

When was MINAMO approved by the FDA?

MINAMO received FDA 510(k) clearance on 2019-08-01, under approval number K190176.

What company makes MINAMO?

MINAMO is manufactured by Asahi Intecc Co., Ltd..

What is the FDA product code for MINAMO?

The FDA product code for MINAMO is DQX.

Other Devices by Asahi Intecc 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.