Device Classification Name |
system, imaging, pulsed echo, ultrasonic
|
510(k) Number |
K902007 |
Device Name |
I3SYSTEM-ABD |
Applicant |
INNOVATIVE IMAGING, INC. |
#97, 52ND ST. |
SACRAMENTO,
CA
95819
|
|
Applicant Contact |
RAINER NIKEL |
Correspondent |
INNOVATIVE IMAGING, INC. |
#97, 52ND ST. |
SACRAMENTO,
CA
95819
|
|
Correspondent Contact |
RAINER NIKEL |
Regulation Number | 892.1560
|
Classification Product Code |
|
Date Received | 05/04/1990 |
Decision Date | 07/20/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|