Hydro-Temp Neonatal Skin Temperature Probe Cover

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 Temperature Probe Cover.

Pre-market Notification Details

Device IDK191425
510k NumberK191425
Device Name:Hydro-Temp Neonatal Skin Temperature Probe Cover
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)
Regulation Medical SpecialtyGeneral Hospital
510k Review PanelGeneral Hospital
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-29
Decision Date2020-01-21
Summary:summary

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