SANITHERM ORAL DISPOSABLE THERMOMETER SHEATHS FOR MERCURY THERMOMETER, SENITHERM ORAL DISPOSABLE THERMOMETER SHEATHS FOR— 510(k) K983406

Substantially Equivalent

Banta Healthcare Group, Ltd.

FDA 510(k) clearance K983406 for SANITHERM ORAL DISPOSABLE THERMOMETER SHEATHS FOR MERCURY THERMOMETER, SENITHERM ORAL DISPOSABLE THERMOMETER SHEATHS FOR, Substantially Equivalent on 1998-10-19. Applicant: Banta Healthcare Group, Ltd..

Clearance details

Applicant: Banta Healthcare Group, Ltd.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 1998-09-28
Decision date: 1998-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Neenah, WI, 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.