FDA 510(k)

MINAMO blue; MINAMO viola

K-Number: K240387 · 2024-06-21

Decision Date2024-06-21

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MINAMO blue; MINAMO viola 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 2024-06-21 under 510(k) number K240387. 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 blue; MINAMO viola?

MINAMO blue; MINAMO viola is a medical device that received FDA 510(k) clearance on 2024-06-21. The listed applicant is Asahi Intecc Co., Ltd.. The 510(k) number is K240387.

When did MINAMO blue; MINAMO viola receive FDA 510(k) clearance?

MINAMO blue; MINAMO viola received FDA 510(k) clearance on 2024-06-21, under 510(k) number K240387.

Who is the listed applicant for MINAMO blue; MINAMO viola?

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 blue; MINAMO viola?

The FDA product code for MINAMO blue; MINAMO viola is DQX.

Other records listing Asahi Intecc Co., Ltd. as applicant

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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.