DISPOSABLE PRESSURE TRANSDUCER— 510(k) K091408

Substantially Equivalent

Shenzhen Ant Hi-Tech Industrial Co., Ltd.

FDA 510(k) clearance K091408 for DISPOSABLE PRESSURE TRANSDUCER, Substantially Equivalent on 2009-08-18. Applicant: Shenzhen Ant Hi-Tech Industrial Co., Ltd..

Clearance details

Applicant: Shenzhen Ant Hi-Tech Industrial Co., Ltd.
Product code: Code DRS
Advisory panel: Cardiovascular
Date received: 2009-05-12
Decision date: 2009-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, 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.