Cleared Abbreviated

Airborne Phototherapy Light

K160238 · International Biomedical · General Hospital
Jun 2016
Decision
134d
Days
Class 2
Risk

About This 510(k) Submission

K160238 is an FDA 510(k) clearance for the Airborne Phototherapy Light, a Unit, Neonatal Phototherapy (Class II — Special Controls, product code LBI), submitted by International Biomedical (Austin, US). The FDA issued a Cleared decision on June 14, 2016, 134 days after receiving the submission on February 1, 2016. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5700.

Submission Details

510(k) Number K160238 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 2016
Decision Date June 14, 2016
Days to Decision 134 days
Submission Type Abbreviated
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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