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U.S. Department of Health and Human Services

Product Classification
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Device catheter, oximeter, fiber optic, reprocessed
Regulation Description Fiberoptic oximeter catheter.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeNMB
Submission Type 510(k)
Regulation Number 870.1230
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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