Product Classification

• Device: injector, fluid, non-electrically powered
• Regulation Description: Nonelectrically powered fluid injector.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: KZE
• Submission Type: 510(k)
• Regulation Number: 880.5430
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standard

• ISO 21649 First edition 2006-06-01 Needle-free injectors for medical use -- Requirements and test methods

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.