Cleared Traditional

bili-hut

K190899 · Little Sparrows Technologies, Inc. · General Hospital

Sep 2019

Decision

150d

Days

Class 2

Risk

About This 510(k) Submission

K190899 is an FDA 510(k) clearance for the bili-hut, a Unit, Neonatal Phototherapy (Class II — Special Controls, product code LBI), submitted by Little Sparrows Technologies, Inc. (Winchester, US). The FDA issued a Cleared decision on September 5, 2019, 150 days after receiving the submission on April 8, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5700.

Submission Details

510(k) Number	K190899 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 08, 2019
Decision Date	September 05, 2019
Days to Decision	150 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF