HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor With Interface Cable

Warmer, Infant Radiant

DeRoyal Industries, Inc.

The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for Hydro-temp Neonatal Skin Surface Temperature Sensor, Hydro-temp Neonatal Skin Surface Temperature Sensor With Interface Cable.

Pre-market Notification Details

Device IDK200319
510k NumberK200319
Device Name:HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor With Interface Cable
ClassificationWarmer, Infant Radiant
Applicant DeRoyal Industries, Inc. 200 DeBusk Lane Powell,  TN  37849
ContactSarah Bennett
CorrespondentSarah Bennett
DeRoyal Industries, Inc. 200 DeBusk Lane Powell,  TN  37849
Product CodeFMT  
CFR Regulation Number880.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-07
Decision Date2020-04-02

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