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510(k) K151978

Device
EDAN I15 Blood Gas And Chemistry Analysis System, EDAN I15 Calibrant Fluid Pack, EDAN I15 Blood Gas And Electrolyte Control, EDAN I15 Hematocrit Control
Applicant
EDAN INSTRUMENTS, INC.
510(k) number
K151978
Product code
CHL  
Decision
Substantially Equivalent (SESE)
Decision date
2016-07-15
Date received
2015-07-17
Regulation
862.1120
Classification name
Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
TRACY YUE
Address
3/F-B, Nanshan Medical Equipments Park, #1019 Nanhai Rd. Shenzhen CN 518067 518067

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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K200492i-STAT CG4+ Cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.2020-04-09
K192240RAPIDPoint 500e Blood Gas SystemSiemens Healthcare Diagnostics, Inc.2020-03-27
K193246Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation2020-01-24
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Legacy Summary#

summary

FDA Review#

Decision Summary