THE FEVER-THERM A THERM. MEASURING DEVICE— 510(k) K850395

Substantially Equivalent

Kma, Inc.

FDA 510(k) clearance K850395 for THE FEVER-THERM A THERM. MEASURING DEVICE, Substantially Equivalent on 1985-08-13. Applicant: Kma, Inc..

Clearance details

Applicant: Kma, Inc.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 1985-02-01
Decision date: 1985-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethesda, MD, 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.