Product Classification

• Device: nasopharyngoscope (flexible or rigid)
• Regulation Description: Nasopharyngoscope (flexible or rigid) and accessories.
• Regulation Medical Specialty: Ear Nose & Throat
• Review Panel: Ear Nose & Throat
• Product Code: EOB
• Submission Type: 510(k)
• Regulation Number: 874.4760
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• IEC 60601-2-18: Edition 3.0 2009-08 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
• IEC 60601-2-18:1996 Amendment 1 2000 Medical electrical equipment - Part 2: Particular requirements for the safety of endoscopic equipment

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.