HiCardi+ H100— 510(k) K232670

Substantially Equivalent

MEZOO Co., Ltd.

FDA 510(k) clearance K232670 for HiCardi+ H100, Substantially Equivalent on 2024-09-20. Applicant: MEZOO Co., Ltd..

Clearance details

Applicant: MEZOO Co., Ltd.
Product code: Code DSH
Advisory panel: Cardiovascular
Date received: 2023-09-01
Decision date: 2024-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wonju-Si, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code DSH

product code DSH

Death: 3
Injury: 652
Total: 655

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.