CERNER FETALINK+(VERSION1.0)— 510(k) K121758

Name: FDA 510(k) clearance K121758
Creator: U.S. Food and Drug Administration
Published: 2012-10-09

Substantially Equivalent

Cerner Corp.

FDA 510(k) clearance K121758 for CERNER FETALINK+(VERSION1.0), Substantially Equivalent on 2012-10-09. Applicant: Cerner Corp.. Device class: 2.

Clearance details

Applicant: Cerner Corp.
Product code: Code HGM
Device class: Class 2
Regulation: 21 CFR 884.2740
Advisory panel: Obstetrics/Gynecology
Date received: 2012-06-15
Decision date: 2012-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kansas City, MO, US

Download summary PDF View on FDA.gov ↗

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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.