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510(k) K042675

Device
FLEXI-STAT SP02 EAR SENSOR
Applicant
ELEKON INDUSTRIES U.S.A., INC.
510(k) number
K042675
Product code
DPZ  
Decision
Substantially Equivalent (SESE)
Decision date
2004-12-06
Date received
2004-09-29
Regulation
870.2710
Classification name
Oximeter, Ear
Medical specialty
Cardiovascular
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
KRISTA OAKES
Address
2300 Mcdermott Rd. # 200-207 Plano TX US 75025 75025

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DPZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K040831DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500Datex-Ohmeda, Inc.2004-09-02
K012333FLEXI-SITE SP02 EAR SENSOREpic Medical Equipment Services, Inc.2001-10-17
K010718FLEXI-SITE SP02 EAR SENSOREpic Medical Equipment Services, Inc.2001-03-23
K944760DURA-Y OXYGEN TRANSDUCER, EAR CLIPNellcor, Inc.1994-10-17
K942752MARQUETTE EAR PROBE SENSORMarquette Electronics, Inc.1994-09-02
K914595PULSE RATE MONITORFitness Quest, Inc.1992-01-31
K862426PULSE OXIMETERDraeger Medical, Inc.1986-09-11
K845051VITALOG PMS-8Vitalog Corp.1985-05-15
K850494OHMEDA BIOX 3700 PULSE OXIMETEROhmeda Medical1985-03-28
K810363EAR OXIMETERBio-Tek Instruments, Inc.1981-02-27

Legacy Summary#

summary

FDA Review#

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