TEMPTELLER INFARED EAR THERMOMETERS, MODEL CT-31/31DX/32/32DX— 510(k) K030299

Substantially Equivalent

Oriental System Technology, Inc.

FDA 510(k) clearance K030299 for TEMPTELLER INFARED EAR THERMOMETERS, MODEL CT-31/31DX/32/32DX, Substantially Equivalent on 2003-02-25. Applicant: Oriental System Technology, Inc..

Clearance details

Applicant: Oriental System Technology, Inc.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2003-01-29
Decision date: 2003-02-25
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.