PIONEER U121 SERIES CPAP— 510(k) K041823

Substantially Equivalent

Merits Health Products Co., Ltd.

FDA 510(k) clearance K041823 for PIONEER U121 SERIES CPAP, Substantially Equivalent on 2005-05-10. Applicant: Merits Health Products Co., Ltd..

Clearance details

Applicant: Merits Health Products Co., Ltd.
Product code: Code BZD
Advisory panel: Anesthesiology
Date received: 2004-07-06
Decision date: 2005-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taichung, TW

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.