NPAC DIGITAL THERMOMETER, MODELS ET 300, 301, 350, 351; ET 400, 401, 450, 451; ET 500, 501, 550, 551— 510(k) K031907

Substantially Equivalent

Norm Pacific Automation Corp.

FDA 510(k) clearance K031907 for NPAC DIGITAL THERMOMETER, MODELS ET 300, 301, 350, 351; ET 400, 401, 450, 451; ET 500, 501, 550, 551, Substantially Equivalent on 2003-08-21. Applicant: Norm Pacific Automation Corp..

Clearance details

Applicant: Norm Pacific Automation Corp.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2003-06-20
Decision date: 2003-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
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.