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U.S. Department of Health and Human Services

Product Classification

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Device oximeter, tissue saturation, reprocessed
Regulation Description Oximeter.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeNMD
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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible