EXAC-TEMP & CLINI-TEMP PROBE W/TEMPERATURE SENSOR— 510(k) K925791

Substantially Equivalent

Deroyal Industries, Inc.

FDA 510(k) clearance K925791 for EXAC-TEMP & CLINI-TEMP PROBE W/TEMPERATURE SENSOR, Substantially Equivalent on 1994-02-25. Applicant: Deroyal Industries, Inc..

Clearance details

Applicant: Deroyal Industries, Inc.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 1992-11-16
Decision date: 1994-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Powell, TN, 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.