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FDA PRODUCT CODE · CLASS II

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 880.5700
MEDICAL SPECIALTY
General Hospital
REVIEW PANEL
HO
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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