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U.S. Department of Health and Human Services

Product Classification

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Device monitor, fetal doppler ultrasound
Regulation Description Fetal ultrasonic monitor and accessories.
Regulation Medical Specialty Obstetrics/Gynecology
Review Panel Radiology
Product CodeMAA
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
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
Accredited Persons

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