Device Classification Name |
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
|
510(k) Number |
K122729 |
Device Name |
ABL90 FLEX |
Applicant |
RADIOMETER MEDICAL APS |
AKANDEVEJ 21 |
BRONSHOJ,
DK
DK-2700
|
|
Applicant Contact |
Martin Gabler |
Correspondent |
RADIOMETER MEDICAL APS |
AKANDEVEJ 21 |
BRONSHOJ,
DK
DK-2700
|
|
Correspondent Contact |
Martin Gabler |
Regulation Number | 862.1120
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/06/2012 |
Decision Date | 11/16/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|