K072634

Substantially Equivalent

EMG TRITON -COMP,MODEL NCA01-XXX SERIES

Applicant: Emg Technology Co., Ltd.
Product code: BTI
Advisory panel: Anesthesiology
Date received: 2007-09-18
Decision date: 2008-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shituen Chiu, Taichung, TW

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Adverse events under product code BTI

product code BTI

Death: 25
Malfunction: 1,168
Total: 1,193

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.