NuBorne Infant Warmer
K-Number: K173516 · 2018-08-17
ApplicantInternational Biomedical
Decision Date2018-08-17
Product CodeFMT
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
NuBorne Infant Warmer is a medical device manufactured by International Biomedical. It received FDA 510(k) clearance on 2018-08-17 under approval number K173516. The device is classified under product code FMT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the NuBorne Infant Warmer?
NuBorne Infant Warmer is a medical device that received FDA 510(k) clearance on 2018-08-17. It is manufactured by International Biomedical. The 510(k) number is K173516.
When was NuBorne Infant Warmer approved by the FDA?
NuBorne Infant Warmer received FDA 510(k) clearance on 2018-08-17, under approval number K173516.
What company makes NuBorne Infant Warmer?
NuBorne Infant Warmer is manufactured by International Biomedical.
What is the FDA product code for NuBorne Infant Warmer?
The FDA product code for NuBorne Infant Warmer is FMT.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.