CERNER FETALINK (VERSION 1.0)— 510(k) K091251

Substantially Equivalent

Cerner Corp.

FDA 510(k) clearance K091251 for CERNER FETALINK (VERSION 1.0), Substantially Equivalent on 2009-08-25. Applicant: Cerner Corp..

Clearance details

Applicant: Cerner Corp.
Product code: Code HGM
Advisory panel: Obstetrics/Gynecology
Date received: 2009-04-29
Decision date: 2009-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kansas City, MO, US

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.