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U.S. Department of Health and Human Services

Product Classification

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Device echocardiograph
Regulation Description Echocardiograph.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDXK
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Cardiac Diagnostics Devices Branch (CDDB)
Submission Type 510(k)
Regulation Number 870.2330
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Guidance for Industry and FDA Staff - Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers
Third Party Review
Accredited Persons

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