Type I, Type II, Type III, Type IV— 510(k) K172331

Unknown

Lepu Medical Technology (Beijing) Co., Ltd.

FDA 510(k) clearance K172331 for Type I, Type II, Type III, Type IV, Unknown on 2018-03-02. Applicant: Lepu Medical Technology (Beijing) Co., Ltd..

Clearance details

Applicant: Lepu Medical Technology (Beijing) Co., Ltd.
Product code: Code DYB
Advisory panel: Cardiovascular
Date received: 2017-08-02
Decision date: 2018-03-02
Decision: Unknown
Clearance type: Traditional
Location: Beijing, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code DYB

product code DYB

Death: 808
Injury: 5,922
Malfunction: 16,516
Other: 5
Total: 23,251

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.