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U.S. Department of Health and Human Services

Product Classification

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Device unit, neonatal phototherapy
Regulation Description Neonatal phototherapy unit.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeLBI
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission Type 510(k)
Regulation Number 880.5700
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review
Accredited Persons

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