EUROMEDICAL REINFORCED ENDOTRACHEAL TUBE— 510(k) K962389

Substantially Equivalent

Unomedical Sdn Bhd

FDA 510(k) clearance K962389 for EUROMEDICAL REINFORCED ENDOTRACHEAL TUBE, Substantially Equivalent on 1996-11-21. Applicant: Unomedical Sdn Bhd.

Clearance details

Applicant: Unomedical Sdn Bhd
Product code: Code BTR
Advisory panel: Anesthesiology
Date received: 1996-06-20
Decision date: 1996-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarpon Springs, FL, US

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Adverse events under product code BTR

product code BTR

Death: 92
Injury: 1,263
Malfunction: 7,475
Other: 2
Total: 8,832

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.