Cleared Abbreviated

NuBorne Infant Warmer

K173516 · International Biomedical · General Hospital
Aug 2018
Decision
276d
Days
Class 2
Risk

About This 510(k) Submission

K173516 is an FDA 510(k) clearance for the NuBorne Infant Warmer, a Warmer, Infant Radiant (Class II — Special Controls, product code FMT), submitted by International Biomedical (Austin, US). The FDA issued a Cleared decision on August 17, 2018, 276 days after receiving the submission on November 14, 2017. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5130.

Submission Details

510(k) Number K173516 FDA.gov
FDA Decision Cleared SESE
Date Received November 14, 2017
Decision Date August 17, 2018
Days to Decision 276 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMT — Warmer, Infant Radiant
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5130

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