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U.S. Department of Health and Human Services

Product Classification

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Device oximeter, tissue saturation
Regulation Description Oximeter.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeMUD
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Cardiac Diagnostics Devices Branch (CDDB)
Submission Type 510(k)
Regulation Number 870.2700
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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