Device Classification Name |
computer, diagnostic, programmable
|
510(k) Number |
K092105 |
Device Name |
RADIANALYZER XPRESS |
Applicant |
RADI MEDICAL SYSTEMS AB |
PALMBLADSGATAN 10 |
UPPSALA,
SE
SE-754 50
|
|
Applicant Contact |
MATS GRANLUND |
Correspondent |
RADI MEDICAL SYSTEMS AB |
PALMBLADSGATAN 10 |
UPPSALA,
SE
SE-754 50
|
|
Correspondent Contact |
MATS GRANLUND |
Regulation Number | 870.1425
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/14/2009 |
Decision Date | 10/09/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|