FDA 510(k) Applications for Medical Device Product Code "DPZ"
(Oximeter, Ear)

FDA 510(k) Number Applicant Device Name Decision Date
K040831 DATEX-OHMEDA, INC. DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500 09/02/2004
K042675 ELEKON INDUSTRIES U.S.A., INC. FLEXI-STAT SP02 EAR SENSOR 12/06/2004
K010718 EPIC MEDICAL EQUIPMENT SERVICES, INC. FLEXI-SITE SP02 EAR SENSOR 03/23/2001
K012333 EPIC MEDICAL EQUIPMENT SERVICES, INC. FLEXI-SITE SP02 EAR SENSOR 10/17/2001


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