B-D ASSURE EAR THERMOMETER— 510(k) K971994

Substantially Equivalent

Becton Dickinson Consumer Products

FDA 510(k) clearance K971994 for B-D ASSURE EAR THERMOMETER, Substantially Equivalent on 1998-05-01. Applicant: Becton Dickinson Consumer Products.

Clearance details

Applicant: Becton Dickinson Consumer Products
Product code: Code FLL
Advisory panel: General Hospital
Date received: 1997-05-29
Decision date: 1998-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin Lake, NJ, US

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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.