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U.S. Department of Health and Human Services

Product Classification

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Device monitor, ultrasonic, nonfetal
Regulation Description Nonfetal ultrasonic monitor.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeJAF
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 892.1540
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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