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U.S. Department of Health and Human Services

Product Classification
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Device electrode measurement, drain effluent ph
Regulation Description Blood gases (PCO2, PO2) and blood pH test system.
Definition Measurement of drain effluent pH
Physical State pH potentiometric measurement system
Technical Method pH potentiometric measurement
Target Area drain effluent
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeSFO
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type 510(k)
Regulation Number 862.1120
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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