510(k) K953949— HUMIDIFIER & ACCESSORIES

Substantially Equivalent

Fisher & Paykel Electronics , Ltd.

Clearance details

Applicant: Fisher & Paykel Electronics , Ltd.
Product code: Code CAW
Advisory panel: Anesthesiology
Date received: 1995-08-22
Decision date: 1995-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Auckland, New Zealand, NZ

Adverse events under product code CAW

product code CAW

Death: 204
Injury: 573
Malfunction: 1,400
Other: 6
Total: 2,183

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.