RII INFRARED EAR THERMOMETER, MODEL TH01BN— 510(k) K070976

Substantially Equivalent

Radiant Innovation, Inc.

FDA 510(k) clearance K070976 for RII INFRARED EAR THERMOMETER, MODEL TH01BN, Substantially Equivalent on 2007-04-20. Applicant: Radiant Innovation, Inc..

Clearance details

Applicant: Radiant Innovation, Inc.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2007-04-06
Decision date: 2007-04-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Hsin Chu, TW

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.