Filter and HME/Filter— 510(k) K221472

Substantially Equivalent

Ningbo Huakun Medical Equipment Co., Ltd.

FDA 510(k) clearance K221472 for Filter and HME/Filter, Substantially Equivalent on 2023-02-08. Applicant: Ningbo Huakun Medical Equipment Co., Ltd..

Clearance details

Applicant: Ningbo Huakun Medical Equipment Co., Ltd.
Product code: Code CAH
Advisory panel: Anesthesiology
Date received: 2022-05-20
Decision date: 2023-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cixi, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAH

product code CAH

Death: 7
Total: 7

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.