Product Classification

• Device: mixer, breathing gases, anesthesia inhalation
• Regulation Description: Breathing gas mixer.
• Regulation Medical Specialty: Anesthesiology
• Review Panel: Anesthesiology
• Product Code: BZR
• Submission Type: 510(k)
• Regulation Number: 868.5330
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Third Party Review

• Eligible for Accredited Persons Expansion Pilot Program

Accredited Persons

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