Blanket, Neonatal Phototherapy
The Neonatal Phototherapy Blanket is a general hospital device intended to be used as an adjunct to neonatal phototherapy systems for the treatment of neonatal hyperbilirubinemia (jaundice in newborns). It falls under the General Hospital medical specialty and is classified as a Class 2 device under regulation 880.5700, requiring 510(k) premarket notification. The blanket-style phototherapy device wraps around the neonate to deliver therapeutic light and reduce bilirubin levels. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PDH
- Device Class
- FDA class 2
- Regulation Number
- 880.5700
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.