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U.S. Department of Health and Human Services

Product Classification

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Device recorder,event,implantable cardiac,(without arrhythmia detection)
Regulation Description Medical magnetic tape recorder.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeMXC
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Cardiac Diagnostics Devices Branch (CDDB)
Submission Type 510(k)
Regulation Number 870.2800
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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