FM-1000 PLUS FETAL MONITOR— 510(k) K112187

Name: FDA 510(k) clearance K112187
Creator: U.S. Food and Drug Administration
Published: 2011-09-21

Substantially Equivalent

Advanced Instrumentations, Inc.

FDA 510(k) clearance K112187 for FM-1000 PLUS FETAL MONITOR, Substantially Equivalent on 2011-09-21. Applicant: Advanced Instrumentations, Inc.. Device class: 2.

Clearance details

Applicant: Advanced Instrumentations, Inc.
Product code: Code HGM
Device class: Class 2
Regulation: 21 CFR 884.2740
Advisory panel: Obstetrics/Gynecology
Date received: 2011-07-29
Decision date: 2011-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hialeah, FL, 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.