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FDA 510(k)

HiCardi+ H100

K-Number: K232670 · 2024-09-20

ApplicantMEZOO Co., Ltd.
Decision Date2024-09-20
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HiCardi+ H100 is a medical device manufactured by MEZOO Co., Ltd.. It received FDA 510(k) clearance on 2024-09-20 under approval number K232670. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HiCardi+ H100?

HiCardi+ H100 is a medical device that received FDA 510(k) clearance on 2024-09-20. It is manufactured by MEZOO Co., Ltd.. The 510(k) number is K232670.

When was HiCardi+ H100 approved by the FDA?

HiCardi+ H100 received FDA 510(k) clearance on 2024-09-20, under approval number K232670.

What company makes HiCardi+ H100?

HiCardi+ H100 is manufactured by MEZOO Co., Ltd..

What is the FDA product code for HiCardi+ H100?

The FDA product code for HiCardi+ H100 is DSH.

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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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