FDA 510(k) Applications for Medical Device Product Code "GLY"
(Oximeter To Measure Hemoglobin)

FDA 510(k) Number Applicant Device Name Decision Date
K050014 NIR DIAGNOSTICS, INC. HEMONIR TM 05/05/2005
K955013 NOVA BIOMEDICAL CORP. NOVA CO-OXIMETER ANALYZER 04/25/1996
K993104 NOVA BIOMEDICAL CORP. STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATOR 12/02/1999
K952725 RADIOMETER AMERICA, INC. MULTICHECK 02/20/1996


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