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U.S. Department of Health and Human Services

Product Classification

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Device media,coupling,ultrasound
Regulation Description Diagnostic ultrasonic transducer.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeMUI
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 892.1570
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review
Accredited Persons

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