FETAL ULTRASOUND AND TOCODYNAMOMETER TRANSDUCERS— 510(k) K050826

Substantially Equivalent

Cetro America

FDA 510(k) clearance K050826 for FETAL ULTRASOUND AND TOCODYNAMOMETER TRANSDUCERS, Substantially Equivalent on 2006-04-10. Applicant: Cetro America.

Clearance details

Applicant: Cetro America
Product code: Code HGM
Advisory panel: Obstetrics/Gynecology
Date received: 2005-04-01
Decision date: 2006-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hamden, CT, US

Download summary PDF View on FDA.gov ↗

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.