Device Classification Name |
electrode measurement, blood-gases (pco2, po2) and blood ph
|
510(k) Number |
K043218 |
Device Name |
ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XX |
Applicant |
RADIOMETER MEDICAL APS |
AKANDEVEJ 21 |
BRONSHOJ,
DK
DK-2700
|
|
Applicant Contact |
LENE MEINECHE MARNAES |
Correspondent |
RADIOMETER MEDICAL APS |
AKANDEVEJ 21 |
BRONSHOJ,
DK
DK-2700
|
|
Correspondent Contact |
LENE MEINECHE MARNAES |
Regulation Number | 862.1120
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 11/22/2004 |
Decision Date | 05/10/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|