Pulmogine Vibrating Mesh Nebulizer— 510(k) K202171

Substantially Equivalent

Hcmed Innovations Co., Ltd.

FDA 510(k) clearance K202171 for Pulmogine Vibrating Mesh Nebulizer, Substantially Equivalent on 2021-07-01. Applicant: Hcmed Innovations Co., Ltd..

Clearance details

Applicant: Hcmed Innovations Co., Ltd.
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 2020-08-03
Decision date: 2021-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei City, TW

Download summary PDF View on FDA.gov ↗

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.