TRANSDUCER FOR ULTRASOUND FETAL MONITORING, MODELS FM10833 AND FM10834— 510(k) K040819

Substantially Equivalent

American I.V. Products, Inc.

FDA 510(k) clearance K040819 for TRANSDUCER FOR ULTRASOUND FETAL MONITORING, MODELS FM10833 AND FM10834, Substantially Equivalent on 2004-08-16. Applicant: American I.V. Products, Inc..

Clearance details

Applicant: American I.V. Products, Inc.
Product code: Code HGM
Advisory panel: Obstetrics/Gynecology
Date received: 2004-03-30
Decision date: 2004-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hanover, MD, 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.