CENTRAL MONITORING SYSTEM— 510(k) K143695

Substantially Equivalent

Edan Instruments, Inc.

FDA 510(k) clearance K143695 for CENTRAL MONITORING SYSTEM, Substantially Equivalent on 2015-03-30. Applicant: Edan Instruments, Inc..

Clearance details

Applicant: Edan Instruments, Inc.
Product code: Code HGM
Advisory panel: Obstetrics/Gynecology
Date received: 2014-12-24
Decision date: 2015-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code HGM

product code HGM

Death: 35
Malfunction: 478
Total: 513

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.