TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING— 510(k) K043075

Name: FDA 510(k) clearance K043075
Creator: U.S. Food and Drug Administration
Published: 2005-08-18

Substantially Equivalent

Tenacore Holdings, Inc.

FDA 510(k) clearance K043075 for TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING, Substantially Equivalent on 2005-08-18. Applicant: Tenacore Holdings, Inc.. Device class: 2.

Clearance details

Applicant: Tenacore Holdings, Inc.
Product code: Code HGM
Device class: Class 2
Regulation: 21 CFR 884.2740
Advisory panel: Obstetrics/Gynecology
Date received: 2004-11-08
Decision date: 2005-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, 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.