ELECTRONIC THERMOMETER— 510(k) K131210

Substantially Equivalent

Shenzhen Pump Medical System Co., Ltd.

FDA 510(k) clearance K131210 for ELECTRONIC THERMOMETER, Substantially Equivalent on 2014-03-18. Applicant: Shenzhen Pump Medical System Co., Ltd..

Clearance details

Applicant: Shenzhen Pump Medical System Co., Ltd.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2013-04-29
Decision date: 2014-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, Guangdong, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code FLL

product code FLL

Death: 3
Malfunction: 557
Total: 560

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.