Cleared Traditional

neoBLUE blanket LED Phototherapy System

K182178 · Natus Medical Incorporated · General Hospital
Dec 2018
Decision
122d
Days
Class 2
Risk

About This 510(k) Submission

K182178 is an FDA 510(k) clearance for the neoBLUE blanket LED Phototherapy System, a Unit, Neonatal Phototherapy (Class II — Special Controls, product code LBI), submitted by Natus Medical Incorporated (Seattle, US). The FDA issued a Cleared decision on December 13, 2018, 122 days after receiving the submission on August 13, 2018. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5700.

Submission Details

510(k) Number K182178 FDA.gov
FDA Decision Cleared SESE
Date Received August 13, 2018
Decision Date December 13, 2018
Days to Decision 122 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code LBI — Unit, Neonatal Phototherapy
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5700

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