Cleared Traditional

BiliLux

K172656 · Draeger Medical Systems, Inc. · General Hospital
May 2018
Decision
238d
Days
Class 2
Risk

About This 510(k) Submission

K172656 is an FDA 510(k) clearance for the BiliLux, a Unit, Neonatal Phototherapy (Class II — Special Controls, product code LBI), submitted by Draeger Medical Systems, Inc. (Telford, US). The FDA issued a Cleared decision on May 1, 2018, 238 days after receiving the submission on September 5, 2017. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5700.

Submission Details

510(k) Number K172656 FDA.gov
FDA Decision Cleared SESE
Date Received September 05, 2017
Decision Date May 01, 2018
Days to Decision 238 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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