SINGLE USE ORAL MASK, MODEL HC455A— 510(k) K023670

Substantially Equivalent

Fisher & Paykel Healthcare, Ltd.

FDA 510(k) clearance K023670 for SINGLE USE ORAL MASK, MODEL HC455A, Substantially Equivalent on 2003-06-12. Applicant: Fisher & Paykel Healthcare, Ltd..

Clearance details

Applicant: Fisher & Paykel Healthcare, Ltd.
Product code: Code BZD
Advisory panel: Anesthesiology
Date received: 2002-10-31
Decision date: 2003-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Tamaki, Auckland, NZ

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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.