DeviceClearance

K203078

Substantially Equivalent

CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW

Applicant
Huizhou Tianchang Industrial Co., Ltd.
Product code
FXX
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Abbreviated
Location
Huizhou, CN
Download summary PDF View on FDA.gov ↗

Adverse events under product code FXX

product code FXX
Injury
137
Total
137

Source: openFDA MAUDE database, through . 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.