Product Classification

• Device: ventilator, external body, negative pressure, adult (cuirass)
• Regulation Description: External negative pressure ventilator.
• Regulation Medical Specialty: Anesthesiology
• Review Panel: Anesthesiology
• Product Code: BYT
• Submission Type: 510(k)
• Regulation Number: 868.5935
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Guidance Document

• Draft Reviewer Guidance for Ventilators  

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.