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U.S. Department of Health and Human Services

Product Classification
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Device amnioscope, transabdominal (fetoscope) (and accessories)
Regulation Description Transabdominal amnioscope (fetoscope) and accessories.
Regulation Medical Specialty Obstetrics/Gynecology
Review Panel Obstetrics/Gynecology
Product CodeHFA
Premarket Review Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Reproductive, Gynecology and Urology Devices (DHT3B)
Submission Type HDE - Humanitarian Device Exemption
Regulation Number 884.1600
Device Class HDE
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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