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DPZ — Oximeter, Ear Class II

FDA Device Classification

Classification Details

Product Code
DPZ
Device Class
Class II
Regulation Number
870.2710
Submission Type
Review Panel
AN
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K042675elekon industries u.s.aFLEXI-STAT SP02 EAR SENSORDecember 6, 2004
K040831datex-ohmedaDATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500September 2, 2004
K012333epic medical equipment servicesFLEXI-SITE SP02 EAR SENSOROctober 17, 2001
K010718epic medical equipment servicesFLEXI-SITE SP02 EAR SENSORMarch 23, 2001
K944760nellcorDURA-Y OXYGEN TRANSDUCER, EAR CLIPOctober 17, 1994
K942752marquette electronicsMARQUETTE EAR PROBE SENSORSeptember 2, 1994
K914595fitness questPULSE RATE MONITORJanuary 31, 1992
K862426draeger medicalPULSE OXIMETERSeptember 11, 1986
K845051vitalogVITALOG PMS-8May 15, 1985
K850494ohmeda medicalOHMEDA BIOX 3700 PULSE OXIMETERMarch 28, 1985
K810363bio-tek instrumentsEAR OXIMETERFebruary 27, 1981