Device Classification Name |
electrode measurement, blood-gases (pco2, po2) and blood ph
|
510(k) Number |
K051804 |
Device Name |
ABL80 FLEX ANALYZER |
Applicant |
SENDX MEDICAL, INC. |
1945 PALOMAR OAKS WAY |
CARLSBAD,
CA
92011
|
|
Applicant Contact |
DOREEN E MILFORD |
Correspondent |
SENDX MEDICAL, INC. |
1945 PALOMAR OAKS WAY |
CARLSBAD,
CA
92011
|
|
Correspondent Contact |
DOREEN E MILFORD |
Regulation Number | 862.1120
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/05/2005 |
Decision Date | 11/01/2005 |
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
|
|
|