Hydro-Temp Neonatal Skin Temperature Probe Cover— 510(k) K191425

Substantially Equivalent

Deroyal Industries, Inc.

FDA 510(k) clearance K191425 for Hydro-Temp Neonatal Skin Temperature Probe Cover, Substantially Equivalent on 2020-01-21. Applicant: Deroyal Industries, Inc..

Clearance details

Applicant: Deroyal Industries, Inc.
Product code: Code FMT
Advisory panel: General Hospital
Date received: 2019-05-29
Decision date: 2020-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Powell, TN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMT

product code FMT

Death: 4
Malfunction: 3,074
Total: 3,078

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.