FDA 510(k)

HiCardi+ H100

K-Number: K232670 · 2024-09-20

Decision Date2024-09-20

Product CodeDSH

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

HiCardi+ H100 is the device name listed in this FDA 510(k) record. The listed applicant is MEZOO Co., Ltd.. It received FDA 510(k) clearance on 2024-09-20 under 510(k) 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. The listed applicant is MEZOO Co., Ltd.. The 510(k) number is K232670.

When did HiCardi+ H100 receive FDA 510(k) clearance?

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

Who is the listed applicant for HiCardi+ H100?

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

What is the FDA product code for HiCardi+ H100?

The FDA product code for HiCardi+ H100 is DSH.

Related Devices (Code: DSH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.K252389Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc.K253293VitaloJAK Clinic (Model 7100)Vitalograph , Ltd.K243650Zio® monitor (DFG0001)iRhythm Technologies, Inc.K243603AeviceMDAevice Health Pte. , Ltd.K242583AT-Patch (ATP-C130/ATP-C70)Atsens Co., Ltd.

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.