510(k) K091716— MERITS HEALTH PRODUCTS PROFIL Q601 SERIES OXYGEN FILLING ACCESSORY

Substantially Equivalent

Merits Health Products Co., Ltd.

Clearance details

Applicant: Merits Health Products Co., Ltd.
Product code: Code CAW
Advisory panel: Anesthesiology
Date received: 2009-06-10
Decision date: 2010-04-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Taichung, TW

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.