DeviceClearance

Product code PDH— General Hospital

LITTLE ANGELS SWADDLING BLANKET

Classification name
Blanket, Neonatal Phototherapy
Device class
Class 2
Regulation
21 CFR 880.5700
Advisory panel
General Hospital
Total cleared
2
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code PDH under 21 CFR 880.5700, via openFDA

Market context for product code PDH

FDA has cleared 2 devices under product code PDH between 2013 and 2015, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PDH

Recent clearances under product code PDH

Data sourced from openFDA. This site is unofficial and independent of the FDA.