Disposable Pressure Transducer— 510(k) K152472

Substantially Equivalent

Zhejiang Haisheng Medical Device Co., Ltd.

FDA 510(k) clearance K152472 for Disposable Pressure Transducer, Substantially Equivalent on 2016-10-31. Applicant: Zhejiang Haisheng Medical Device Co., Ltd..

Clearance details

Applicant: Zhejiang Haisheng Medical Device Co., Ltd.
Product code: Code DRS
Advisory panel: Cardiovascular
Date received: 2015-08-31
Decision date: 2016-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shaoxing, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRS

product code DRS

Death: 8
Malfunction: 776
Total: 784

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.