Product Classification

• Device: continuous, ventilator, home use
• Regulation Description: Continuous ventilator.
• Definition: This product code was needed for the home use indication. CBK is not a tracked device and NOU is a tracked device.
• Regulation Medical Specialty: Anesthesiology
• Review Panel: Anesthesiology
• Product Code: NOU
• Premarket Review: Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C); Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
• Submission Type: 510(k)
• Regulation Number: 868.5895
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: Yes

Recognized Consensus Standards

• 1-105 ISO 80601-2-72 First edition 2015-04-11
  Medical electrical equipment - Part 2-72: Particular requirements for basic safely and essential performance of home healthcare environment ventilators for ventilator-dependent patients
• 1-134 ISO 18562-1 First edition 2017-03
  Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process
• 1-135 ISO 18562-2 First edition 2017-03
  Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter
• 1-136 ISO 18562-3 First edition 2017-03
  Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds
• 1-137 ISO 18562-4 First edition 2017-03
  Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate
• 1-138 ISO 80601-2-74 First edition 2017-05
  Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
• 1-163 ISO 80601-2-72 Second edition 2023-06
  Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients

Third Party Review

Not Third Party Eligible