Product Classification

• Device: monitor, fetal doppler ultrasound
• Regulation Description: Fetal ultrasonic monitor and accessories.
• Regulation Medical Specialty: Obstetrics/Gynecology
• Review Panel: Radiology
• Product Code: MAA
• Submission Type: 510(k)
• Regulation Number: 884.2660
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Guidance Document

• Guidance for Industry and FDA Staff - Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers

Third Party Review

• Eligible for Accredited Persons Program

Accredited Persons

• bsi healthcare
• center for measurement standards of industrial
• dekra certification b.v.
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.