Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K122329 |
Device Name |
BIOJET |
Applicant |
JET SOFT SRL |
STR. ANASTTASIE PANU NR. 6 |
BUCHAREST,
RO
031164
|
|
Applicant Contact |
PETER-M KLEWS |
Correspondent |
TUV SUD AMERICA INC. |
1775 OLD HIGHWAY 8 NW |
NEW BRIGHTON,
MN
55112 -1891
|
|
Correspondent Contact |
OLAF TEICHERT |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 08/01/2012 |
Decision Date | 08/16/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|