WIRELESS THERMOMETER— 510(k) K132761

Substantially Equivalent

Raiing Medical Company

FDA 510(k) clearance K132761 for WIRELESS THERMOMETER, Substantially Equivalent on 2014-07-08. Applicant: Raiing Medical Company.

Clearance details

Applicant: Raiing Medical Company
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2013-09-04
Decision date: 2014-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beijing, 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.