Product Classification

• Device: analyzer, gas, halothane, gaseous-phase (anesthetic conc.)
• Regulation Description: Halothane gas analyzer.
• Regulation Medical Specialty: Anesthesiology
• Review Panel: Anesthesiology
• Product Code: CBS
• Submission Type: 510(k)
• Regulation Number: 868.1620
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• ISO 21647:2004 TECHINCAL CORRIGENDUM 1 Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors
• ISO 21647:2004 Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors

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.