PIONEER U601 SERIES ASPIRATOR— 510(k) K052650

Substantially Equivalent

Merits Health Products Co., Ltd.

FDA 510(k) clearance K052650 for PIONEER U601 SERIES ASPIRATOR, Substantially Equivalent on 2005-11-04. Applicant: Merits Health Products Co., Ltd..

Clearance details

Applicant: Merits Health Products Co., Ltd.
Product code: Code BTA
Advisory panel: General, Plastic Surgery
Date received: 2005-09-26
Decision date: 2005-11-04
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Taichung, TW

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Adverse events under product code BTA

product code BTA

Death: 5
Total: 5

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.