Digital Thermometer— 510(k) K161211

Substantially Equivalent

Biocare Asia Corporation , Ltd.

FDA 510(k) clearance K161211 for Digital Thermometer, Substantially Equivalent on 2016-08-29. Applicant: Biocare Asia Corporation , Ltd..

Clearance details

Applicant: Biocare Asia Corporation , Ltd.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2016-04-28
Decision date: 2016-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, 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.