Product Classification

• Device: warmer, infant radiant
• Regulation Description: Infant radiant warmer.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: FMT
• Submission Type: 510(k)
• Regulation Number: 880.5130
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• AAMI/ANSI/IEC 60601-2-21:2009 Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
• IEC 60601-2-21 1996 Amendment 1:2000 - Medical electrical equipment Part 2: Particular requirements for safety of infant radiant warmers
• AAMI/ANSI/IEC 60601-2-21 and 60601-2-21 Amendment 1:2000 Medical electrical equipment - Part 2: Particular requirements for safety of infant radiant warmers

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.