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U.S. Department of Health and Human Services

Product Classification

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Device monitor and/or control, level sensing, cardiopulmonary bypass
Regulation Description Cardiopulmonary bypass level sensing monitor and/or control.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDTW
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Circulatory Support Devices Branch (CSDB)
Submission Type 510(k)
Regulation Number 870.4340
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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