BESMED JET NEBULIZER BOTTLE SET— 510(k) K091272

Substantially Equivalent

Besmed Health Business Corp

FDA 510(k) clearance K091272 for BESMED JET NEBULIZER BOTTLE SET, Substantially Equivalent on 2009-11-10. Applicant: Besmed Health Business Corp.

Clearance details

Applicant: Besmed Health Business Corp
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 2009-04-30
Decision date: 2009-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsin Chu 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.