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U.S. Department of Health and Human Services

Product Classification

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Device adaptor, lead switching, electrocardiograph
Regulation Description Electrocardiograph lead switching adaptor.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDRW
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Cardiac Diagnostics Devices Branch (CDDB)
Submission Type 510(k)
Regulation Number 870.2350
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Electrocardiograph (ECG) Lead Switching Adapter [http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080227.pdf] 
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons