Blanket, Neonatal Phototherapy

PDH · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.5700

Classification

FDA Product Code: PDH
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 880.5700
Review panel: HO
Medical specialty: General Hospital
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

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.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 4

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown