JOINSOON ELECTRONICS MFG CO., LTD INFRARED EAR THERMOMETER, MODEL TT-001— 510(k) K101322

Substantially Equivalent

Joinsoon Electronics Mfg Co, Ltd.

FDA 510(k) clearance K101322 for JOINSOON ELECTRONICS MFG CO., LTD INFRARED EAR THERMOMETER, MODEL TT-001, Substantially Equivalent on 2010-07-28. Applicant: Joinsoon Electronics Mfg Co, Ltd..

Clearance details

Applicant: Joinsoon Electronics Mfg Co, Ltd.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2010-05-11
Decision date: 2010-07-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Great Neck, NY, US

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.