CNS-2101 Central Monitor— 510(k) K223567

Substantially Equivalent

Nihon Kohden Corporation

FDA 510(k) clearance K223567 for CNS-2101 Central Monitor, Substantially Equivalent on 2023-07-31. Applicant: Nihon Kohden Corporation.

Clearance details

Applicant: Nihon Kohden Corporation
Product code: Code MSX
Advisory panel: Cardiovascular
Date received: 2022-11-29
Decision date: 2023-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code MSX

product code MSX

Death: 59
Total: 59

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.