Product Classification

• Device: nystagmograph
• Regulation Description: Nystagmograph.
• Regulation Medical Specialty: Neurology
• Review Panel: Neurology
• Product Code: GWN
• Submission Type: 510(k)
• Regulation Number: 882.1460
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standard

• S3.45-2009 (Revision of ANSI S3.45-1999) American National Standard Procedures for Testing Basic Vestibular Function

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.