PHILIPS AVENT DIGITAL THERMOMETER SET, MODEL SCH540— 510(k) K100495

Substantially Equivalent

Philips Electronics UK Limited

FDA 510(k) clearance K100495 for PHILIPS AVENT DIGITAL THERMOMETER SET, MODEL SCH540, Substantially Equivalent on 2010-06-22. Applicant: Philips Electronics UK Limited.

Clearance details

Applicant: Philips Electronics UK Limited
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2010-02-19
Decision date: 2010-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glemsford, Suffolk, GB

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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.