DeRoyal Temperature Monitoring Probe— 510(k) K200631

Substantially Equivalent

Deroyal Industries, Inc.

FDA 510(k) clearance K200631 for DeRoyal Temperature Monitoring Probe, Substantially Equivalent on 2020-12-23. Applicant: Deroyal Industries, Inc..

Clearance details

Applicant: Deroyal Industries, Inc.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2020-03-10
Decision date: 2020-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Powell, TN, US

Download summary PDF View on FDA.gov ↗

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.