Product Classification

• Device: ventilator, continuous, non-life-supporting
• Regulation Description: Continuous ventilator.
• Regulation Medical Specialty: Anesthesiology
• Review Panel: Anesthesiology
• Product Code: MNS
• Submission Type: 510(k)
• Regulation Number: 868.5895
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• ISO 80601-2-12 First edition 2011-04-15 Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators
• ISO 80601-2-12 Technical Corrigendum 1 Medical electrical equipment Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
• IEC 60601-2-12:(2001-10): Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators
• ISO 5356-1 Third edition 2004-05-15 Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets

Guidance Document

• Draft Reviewer Guidance for Ventilators  

Third Party Review

Not Third Party Eligible