K230476

Substantially Equivalent

Oran Park Mask

Applicant: Resmed Pty Ltd (Registration Number: 3004604967)
Product code: BZD
Advisory panel: Anesthesiology
Date received: 2023-02-22
Decision date: 2023-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bella Vista, AU

Adverse events under product code BZD

product code BZD

Death: 4,440
Injury: 53,099
Malfunction: 213,222
Other: 17
Total: 270,778

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.