Cleared Traditional

HiCardi+ H100

K232670 · MEZOO Co., Ltd. · Cardiovascular
Sep 2024
Decision
385d
Days
Class 2
Risk

About This 510(k) Submission

K232670 is an FDA 510(k) clearance for the HiCardi+ H100, a Recorder, Magnetic Tape, Medical (Class II — Special Controls, product code DSH), submitted by MEZOO Co., Ltd. (Wonju-Si, KR). The FDA issued a Cleared decision on September 20, 2024, 385 days after receiving the submission on September 1, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2800.

Submission Details

510(k) Number K232670 FDA.gov
FDA Decision Cleared SESE
Date Received September 01, 2023
Decision Date September 20, 2024
Days to Decision 385 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DSH — Recorder, Magnetic Tape, Medical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2800