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U.S. Department of Health and Human Services

Product Classification

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Device system, imaging, holography, acoustic
Regulation Description Ultrasonic pulsed doppler imaging system.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeNCS
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 892.1550
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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