HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS— 510(k) K082009

Substantially Equivalent

Hsiner Co., Ltd.

FDA 510(k) clearance K082009 for HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS, Substantially Equivalent on 2008-08-22. Applicant: Hsiner Co., Ltd..

Clearance details

Applicant: Hsiner Co., Ltd.
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 2008-07-23
Decision date: 2008-08-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Temecula, CA, US

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.