Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System— 510(k) K203435

Substantially Equivalent

Nihon Kohden Corporation

FDA 510(k) clearance K203435 for Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System, Substantially Equivalent on 2021-07-16. Applicant: Nihon Kohden Corporation.

Clearance details

Applicant: Nihon Kohden Corporation
Product code: Code MHX
Advisory panel: Cardiovascular
Date received: 2020-11-23
Decision date: 2021-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code MHX

product code MHX

Death: 580
Injury: 2,441
Malfunction: 12,655
Other: 3
Total: 15,679

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.