Device Classification Name |
accelerator, linear, medical
|
510(k) Number |
K040585 |
Device Name |
EXACTRAC 4.0 AND EXACTRAC X-RAY 6D |
Applicant |
BRAINLAB AG |
AMMERTHALSTRASSE 8 |
HEIMSTETTEN,
DE
85551
|
|
Applicant Contact |
RAINER BIRKENBACH |
Correspondent |
BRAINLAB AG |
AMMERTHALSTRASSE 8 |
HEIMSTETTEN,
DE
85551
|
|
Correspondent Contact |
RAINER BIRKENBACH |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 03/05/2004 |
Decision Date | 05/11/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|