XOMED-TREACE EMG ENDOTRACHEAL TUBEEN— 510(k) K925640

Substantially Equivalent

Xomed-Treace, Inc.

FDA 510(k) clearance K925640 for XOMED-TREACE EMG ENDOTRACHEAL TUBEEN, Substantially Equivalent on 1993-08-17. Applicant: Xomed-Treace, Inc..

Clearance details

Applicant: Xomed-Treace, Inc.
Product code: Code ETN
Advisory panel: Ear, Nose, Throat
Date received: 1992-11-09
Decision date: 1993-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

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Adverse events under product code ETN

product code ETN

Death: 7
Injury: 327
Malfunction: 2,776
Total: 3,110

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.