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

FDA 510(k) Number Applicant Device Name Decision Date
K810363 BIO-TEK INSTRUMENTS, INC. EAR OXIMETER 02/27/1981
K040831 DATEX-OHMEDA, INC. DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500 09/02/2004
K862426 DRAEGER MEDICAL, INC. PULSE OXIMETER 09/11/1986
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
K914595 FITNESS QUEST, INC. PULSE RATE MONITOR 01/31/1992
K942752 MARQUETTE ELECTRONICS, INC. MARQUETTE EAR PROBE SENSOR 09/02/1994
K944760 NELLCOR, INC. DURA-Y OXYGEN TRANSDUCER, EAR CLIP 10/17/1994
K850494 OHMEDA MEDICAL OHMEDA BIOX 3700 PULSE OXIMETER 03/28/1985
K845051 VITALOG CORP. VITALOG PMS-8 05/15/1985


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