Cleared Traditional

Neonatal Phototherapy System

K200031 · Avalon Biomedical (Shenzhen) Limited · General Hospital

Oct 2020

Decision

272d

Days

Class 2

Risk

About This 510(k) Submission

K200031 is an FDA 510(k) clearance for the Neonatal Phototherapy System, a Unit, Neonatal Phototherapy (Class II — Special Controls, product code LBI), submitted by Avalon Biomedical (Shenzhen) Limited (Longhua District, CN). The FDA issued a Cleared decision on October 5, 2020, 272 days after receiving the submission on January 7, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5700.

Submission Details

510(k) Number	K200031 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 07, 2020
Decision Date	October 05, 2020
Days to Decision	272 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF