Cleared Traditional

LITTLE ANGELS SWADDLING BLANKET

K123411 · Bionix Development Corp. · General Hospital
Mar 2013
Decision
122d
Days
Class 2
Risk

About This 510(k) Submission

K123411 is an FDA 510(k) clearance for the LITTLE ANGELS SWADDLING BLANKET, a Blanket, Neonatal Phototherapy (Class II — Special Controls, product code PDH), submitted by Bionix Development Corp. (Toledo, US). The FDA issued a Cleared decision on March 7, 2013, 122 days after receiving the submission on November 5, 2012. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5700.

Submission Details

510(k) Number K123411 FDA.gov
FDA Decision Cleared SESE
Date Received November 05, 2012
Decision Date March 07, 2013
Days to Decision 122 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code PDH — Blanket, Neonatal Phototherapy
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5700
Definition Is Intended To Be Used As An Adjunct To Neonatal Phototherapy Systems Used For The Treatment Of Neonatal Hyperbilirubinemia In The Clinical Or Home Setting.