Product Classification

• Device: incubator, neonatal transport
• Regulation Description: Neonatal transport incubator.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: FPL
• Premarket Review: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3); Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
• Submission Type: 510(k)
• Regulation Number: 880.5410
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standard

• 6-462 IEC 60601-2-20 Edition 3.0 2020-09
  Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• beanstock consulting
• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc