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並前往https://www.accessdata.fda.gov/cdrh_docs/reviews/K160415.pdf

REVIEW MEMORANDUM - Accessdata.fda.gov

CO -OX: CO-Oximetry (tHb, O2Hb, COHb, MetHb, HHb and sO2) is based on an optical absorbance measurement of the sample. An in‐line optical cell is integrated ...

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