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FDA 510(k)

MINAMO

K-Number: K190176 · 2019-08-01

ApplicantAsahi Intecc Co., Ltd.
Decision Date2019-08-01
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MINAMO is the device name listed in this FDA 510(k) record. The listed applicant is Asahi Intecc Co., Ltd.. It received FDA 510(k) clearance on 2019-08-01 under 510(k) 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. The listed applicant is Asahi Intecc Co., Ltd.. The 510(k) number is K190176.

When did MINAMO receive FDA 510(k) clearance?

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

Who is the listed applicant for MINAMO?

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

What is the FDA product code for MINAMO?

The FDA product code for MINAMO is DQX.

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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.

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