510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PDHClass II

Blanket, Neonatal Phototherapy

21 CFR 880.5700 / General Hospital
FDA source (opens on fda.gov)

PDH is the FDA product code for Blanket, Neonatal Phototherapy, a class II device type, regulated under 21 CFR 880.5700. FDA's definition for this code reads: "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". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
PDH
Device name
Blanket, Neonatal Phototherapy
FDA 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.
Regulation
21 CFR 880.5700
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
2
Ingested recalls
1

Clearances, product code PDH

By decision year
2 clearances under product code PDH with a decision year between 2013 and 2015, 2013 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PDH by decision year
YearClearances
20131
20151

Applicants with the most clearances

Product code PDH
Applicants holding the most 510(k) clearances under product code PDH
ApplicantClearances
Bionix Development Corp.1
Salter Labs1

Companies listing this code with FDA

Companies whose registered establishments list this code