GENESIS TM FETAL SYSTEM— 510(k) K882084

Name: FDA 510(k) clearance K882084
Creator: U.S. Food and Drug Administration
Published: 1989-05-26

Substantially Equivalent

Pediatric Diagnostic Service

FDA 510(k) clearance K882084 for GENESIS TM FETAL SYSTEM, Substantially Equivalent on 1989-05-26. Applicant: Pediatric Diagnostic Service. Device class: 2.

Clearance details

Applicant: Pediatric Diagnostic Service
Product code: Code HGM
Device class: Class 2
Regulation: 21 CFR 884.2740
Advisory panel: Obstetrics/Gynecology
Date received: 1988-05-18
Decision date: 1989-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marietta, GA, 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.