F&P Eson 2 Nasal Mask— 510(k) K153505

Substantially Equivalent

Fisher & Paykel Healthcare Limited

FDA 510(k) clearance K153505 for F&P Eson 2 Nasal Mask, Substantially Equivalent on 2016-09-20. Applicant: Fisher & Paykel Healthcare Limited.

Clearance details

Applicant: Fisher & Paykel Healthcare Limited
Product code: Code BZD
Advisory panel: Anesthesiology
Date received: 2015-12-07
Decision date: 2016-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Auckland, NZ

Download summary PDF View on FDA.gov ↗

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.