Device Classification Name |
system, measurement, blood-pressure, non-invasive
|
510(k) Number |
K122443 |
Device Name |
UFIT TEN-10 |
Applicant |
BIOSIGN TECHNOLOGIES, INC. |
9001 WESLEYAN RD, SUITE 200 |
INDIANAPOLIS,
IN
46268
|
|
Applicant Contact |
ALLISON SCOTT, RAC |
Correspondent |
BIOSIGN TECHNOLOGIES, INC. |
9001 WESLEYAN RD, SUITE 200 |
INDIANAPOLIS,
IN
46268
|
|
Correspondent Contact |
ALLISON SCOTT, RAC |
Regulation Number | 870.1130
|
Classification Product Code |
|
Date Received | 08/10/2012 |
Decision Date | 11/20/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|