HOLDEN-WALKER HUMIDIFIER-NEBULIZER KIT— 510(k) K963917

Unknown

Holden Walker Corp.

FDA 510(k) clearance K963917 for HOLDEN-WALKER HUMIDIFIER-NEBULIZER KIT, Unknown on 1997-02-25. Applicant: Holden Walker Corp..

Clearance details

Applicant: Holden Walker Corp.
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 1996-09-30
Decision date: 1997-02-25
Decision: Unknown
Clearance type: Traditional
Location: Naples, FL, 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.