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U.S. Department of Health and Human Services

Product Classification

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Device doppler, fetal, ultrasound
Regulation Description Fetal ultrasonic monitor and accessories.
Regulation Medical Specialty Obstetrics/Gynecology
Review Panel Radiology
Product CodeLXE
Premarket Review Office of Radiological Health (OHT8)
Radiological Imaging and Radiation Therapy Devices (DHT8C)
Submission Type 510(k)
Regulation Number 884.2660
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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