510(k) K993104

STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATOR by Nova Biomedical Corp. — Product Code GLY

K993104 is an FDA 510(k) premarket notification submitted by Nova Biomedical Corp. for the device "STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATOR". The FDA issued a decision of Substantially Equivalent on December 2, 1999. The device falls under product code GLY (Oximeter To Measure Hemoglobin), a Class II device regulated under 21 CFR 864.7500. Nova Biomedical Corp. has at least 10 other 510(k) clearances on record.