NPAC MULTI-USE EAR THERMOMETER, MODELS TD 600,610,620,630,602,612,622,632, TN 600,610,620,630,602,612,622,632, TS 600,6— 510(k) K030126

Substantially Equivalent

Norm Pacific Automation Corp.

FDA 510(k) clearance K030126 for NPAC MULTI-USE EAR THERMOMETER, MODELS TD 600,610,620,630,602,612,622,632, TN 600,610,620,630,602,612,622,632, TS 600,6, Substantially Equivalent on 2003-02-07. Applicant: Norm Pacific Automation Corp..

Clearance details

Applicant: Norm Pacific Automation Corp.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2003-01-14
Decision date: 2003-02-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Hsin-Chu, TW

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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.