Product Classification

• Device: computer, diagnostic, pre-programmed, single-function
• Regulation Description: Single-function, preprogrammed diagnostic computer.
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Product Code: DXG
• Submission Type: 510(k)
• Regulation Number: 870.1435
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

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.