Device Classification Name |
Probe, Blood-Flow, Extravascular
|
510(k) Number |
K121429 |
Device Name |
AIMAGO EASYLDI MICROCIRCULATION CAMERA |
Applicant |
AIMAGO SA |
PARC SCIENTIFIQUE EPFL, |
PSE-D, 4TH FLOOR |
LAUSANNE,
CH
1015
|
|
Applicant Contact |
MARC ANDRE |
Correspondent |
AIMAGO SA |
PARC SCIENTIFIQUE EPFL, |
PSE-D, 4TH FLOOR |
LAUSANNE,
CH
1015
|
|
Correspondent Contact |
MARC ANDRE |
Regulation Number | 870.2120
|
Classification Product Code |
|
Date Received | 05/14/2012 |
Decision Date | 08/10/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|