PDH · Class II · 21 CFR 880.5700

FDA Product Code PDH: Blanket, Neonatal Phototherapy

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.

Leading manufacturers include Bionix Development Corp. and Salter Labs.

Total

Cleared

205d

Avg days

2013

Since

FDA 510(k) Cleared Blanket, Neonatal Phototherapy Devices (Product Code PDH)

2 devices

1–2 of 2

General Hospital · 288d

Cleared Mar 07, 2013

LITTLE ANGELS SWADDLING BLANKET

K123411

Bionix Development Corp.

General Hospital · 122d

About Product Code PDH - Regulatory Context

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Data Source

FDA 510(k) public files . 175,972 total devices indexed.

Latest clearance: Jun 12, 2015

Product Code Info

Code	PDH
Device class	Class II
CFR	21 CFR 880.5700
Panel	General Hospital

Verify on FDA.gov

View PDH classification on FDA.gov →