Product Classification

• Device: accessory to continuous ventilator (respirator)
• Regulation Description: Continuous ventilator.
• Regulation Medical Specialty: Anesthesiology
• Review Panel: Anesthesiology
• Product Code: MOD
• Premarket Review: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1); 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: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standard

• 1-189 ISO 4135 Fourth edition 2022-01
  Anaesthetic and respiratory equipment - Vocabulary

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• beanstock consulting
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc