DeRoyal Temperature Monitoring Probe

Thermometer, Electronic, Clinical

DeRoyal Industries, Inc.

The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for Deroyal Temperature Monitoring Probe.

Pre-market Notification Details

Device IDK200631
510k NumberK200631
Device Name:DeRoyal Temperature Monitoring Probe
ClassificationThermometer, Electronic, Clinical
Applicant DeRoyal Industries, Inc. 200 DeBusk Lane Powell,  TN  37849
ContactSarah Bennett
CorrespondentSarah Bennett
DeRoyal Industries, Inc. 200 DeBusk Lane Powell,  TN  37849
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-10
Decision Date2020-12-23

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.