K052438

Substantially Equivalent

EMG HANDLE NEBULIZER NB02 SERIES

Applicant: Emg Technology Co., Ltd.
Product code: CAF
Advisory panel: Anesthesiology
Date received: 2005-09-06
Decision date: 2006-01-31
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Wilkes Barre, PA, US

Adverse events under product code CAF

product code CAF

Death: 22
Injury: 125
Malfunction: 613
Other: 11
Total: 771

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.