Product Classification

• Device: heater, breathing system w/wo controller (not humidifier or nebulizer
• Regulation Description: Breathing system heater.
• Regulation Medical Specialty: Anesthesiology
• Review Panel: Anesthesiology
• Product Code: BZE
• Submission Type: 510(k)
• Regulation Number: 868.5270
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standard

• ISO 8185 Third edition 2007-07-01 Corrected verions 2008-06-15 Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems

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.