Cleared Traditional

Infant Phototherapy Equipment

K210289 · Bistos Co., Ltd. · General Hospital
May 2021
Decision
115d
Days
Class 2
Risk

About This 510(k) Submission

K210289 is an FDA 510(k) clearance for the Infant Phototherapy Equipment, a Unit, Neonatal Phototherapy (Class II — Special Controls, product code LBI), submitted by Bistos Co., Ltd. (Seongnam-Si, KR). The FDA issued a Cleared decision on May 28, 2021, 115 days after receiving the submission on February 2, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5700.

Submission Details

510(k) Number K210289 FDA.gov
FDA Decision Cleared SESE
Date Received February 02, 2021
Decision Date May 28, 2021
Days to Decision 115 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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