Device Classification Name |
system, nuclear magnetic resonance imaging
|
510(k) Number |
K033485 |
FOIA Releasable 510(k) |
K033485
|
Device Name |
ENDOSCOUT |
Applicant |
ROBIN MEDICAL, INC. |
MIZPE AVIV |
INDUSTRIAL PARK 13 |
M.P. MISGAV,
IL
20187
|
|
Applicant Contact |
BENNY ARAZY |
Correspondent |
ROBIN MEDICAL, INC. |
MIZPE AVIV |
INDUSTRIAL PARK 13 |
M.P. MISGAV,
IL
20187
|
|
Correspondent Contact |
BENNY ARAZY |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 11/04/2003 |
Decision Date | 04/20/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|