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U.S. Department of Health and Human Services

Product Classification
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Device sensor, blood-gas, in-line, cardiopulmonary bypass
Regulation Description Cardiopulmonary bypass in-line blood gas sensor.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDTY
Submission Type 510(k)
Regulation Number 870.4410
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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