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FDA 510(k)

MCG-S (AM1000)

K-Number: K232823 · 2024-04-05

ApplicantAmcg Co., Ltd.
Decision Date2024-04-05
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MCG-S (AM1000) is a medical device manufactured by Amcg Co., Ltd.. It received FDA 510(k) clearance on 2024-04-05 under approval number K232823. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MCG-S (AM1000)?

MCG-S (AM1000) is a medical device that received FDA 510(k) clearance on 2024-04-05. It is manufactured by Amcg Co., Ltd.. The 510(k) number is K232823.

When was MCG-S (AM1000) approved by the FDA?

MCG-S (AM1000) received FDA 510(k) clearance on 2024-04-05, under approval number K232823.

What company makes MCG-S (AM1000)?

MCG-S (AM1000) is manufactured by Amcg Co., Ltd..

What is the FDA product code for MCG-S (AM1000)?

The FDA product code for MCG-S (AM1000) is DPS.

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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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