CAREGIVER PROFESSIONAL CLINICAL THERMOMETER, PRO-TF SERIES— 510(k) K131771

Substantially Equivalent

Thermomedics, Inc.

FDA 510(k) clearance K131771 for CAREGIVER PROFESSIONAL CLINICAL THERMOMETER, PRO-TF SERIES, Substantially Equivalent on 2013-10-07. Applicant: Thermomedics, Inc..

Clearance details

Applicant: Thermomedics, Inc.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2013-06-17
Decision date: 2013-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Taipei City, 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.