MCG-S (AM1000)— 510(k) K232823

Substantially Equivalent

Amcg Co., Ltd.

FDA 510(k) clearance K232823 for MCG-S (AM1000), Substantially Equivalent on 2024-04-05. Applicant: Amcg Co., Ltd..

Clearance details

Applicant: Amcg Co., Ltd.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2023-09-13
Decision date: 2024-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.