TEMPTELLER INFRARED EAR THERMOMETER, MODELS TT-901, TT-911 AND TT-921— 510(k) K001008

Substantially Equivalent

Oriental System Technology, Inc.

FDA 510(k) clearance K001008 for TEMPTELLER INFRARED EAR THERMOMETER, MODELS TT-901, TT-911 AND TT-921, Substantially Equivalent on 2000-04-12. Applicant: Oriental System Technology, Inc..

Clearance details

Applicant: Oriental System Technology, Inc.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2000-03-29
Decision date: 2000-04-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Great Neck, NY, US

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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.