510(k) K182950— Acare Suction Unit

Substantially Equivalent

Acare Technology Co., Ltd.

Clearance details

Applicant: Acare Technology Co., Ltd.
Product code: Code JCX
Advisory panel: General, Plastic Surgery
Date received: 2018-10-23
Decision date: 2019-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Taipei City, TW

Adverse events under product code JCX

product code JCX

Death: 11
Malfunction: 838
Other: 1
Total: 850

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.