Product Classification

• Device: cable, transducer and electrode, patient, (including connector)
• Regulation Description: Patient transducer and electrode cable (including connector).
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Product Code: DSA
• Submission Type: 510(k)
• Regulation Number: 870.2900
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standard

• IEC 60601-2-31 Edition 2.1 2011-09 Medical electrical equipment, Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

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.