510(k) K201380— Livocare Surgical Mask

Substantially Equivalent

Andon Health Co, Ltd.

Clearance details

Applicant: Andon Health Co, Ltd.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2020-05-26
Decision date: 2020-10-07
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Tianjin, CN

Adverse events under product code FXX

product code FXX

Injury: 137
Total: 137

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.