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 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

About Product Code PDH - Regulatory Context

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Data Source

FDA 510(k) public files . 175,730 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 →