Product Classification

• Device: unit, neonatal phototherapy
• Regulation Description: Neonatal phototherapy unit.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: LBI
• 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

• AAMI/ANSI/IEC 60601-2-50:2009 Medical Electrical Equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
• IEC 60601-2-50 Edition 2.0 2009-03 Medical Electrical Equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment

Third Party Review

• Eligible for Accredited Persons Expansion Pilot Program

Accredited Persons

• dekra certification b.v.
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.