MODIFICATION FETAL MONITOR MODEL FM-2— 510(k) K852518

Substantially Equivalent

Advantage Medical Systems, Inc.

FDA 510(k) clearance K852518 for MODIFICATION FETAL MONITOR MODEL FM-2, Substantially Equivalent on 1985-07-05. Applicant: Advantage Medical Systems, Inc..

Clearance details

Applicant: Advantage Medical Systems, Inc.
Product code: Code HGM
Advisory panel: Obstetrics/Gynecology
Date received: 1985-06-12
Decision date: 1985-07-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hamden, CT, US

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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.