NuBorne Infant Warmer

Warmer, Infant Radiant

International Biomedical

The following data is part of a premarket notification filed by International Biomedical with the FDA for Nuborne Infant Warmer.

Pre-market Notification Details

Device IDK173516
510k NumberK173516
Device Name:NuBorne Infant Warmer
ClassificationWarmer, Infant Radiant
Applicant International Biomedical 8206 Cross Park Drive Austin,  TX  78754
ContactAmy Pieper
CorrespondentAmy Pieper
International Biomedical 8206 Cross Park Drive Austin,  TX  78754
Product CodeFMT  
CFR Regulation Number880.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-11-14
Decision Date2018-08-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00865648000313 K173516 000

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