Device Classification Name |
accelerator, linear, medical
|
510(k) Number |
K073018 |
Device Name |
STEREOTACTIC TARGET POSITIONER, TARGET POSITIONER FOR LEKSELL HEADRING, STEREOTACTIC COUNTERWEIGHT |
Applicant |
BRAINLAB AG |
KAPELLENSTRASSE 12 |
FELDKIRCHEN,
DE
85622
|
|
Applicant Contact |
RAINER BIRKENBACH |
Correspondent |
BRAINLAB AG |
KAPELLENSTRASSE 12 |
FELDKIRCHEN,
DE
85622
|
|
Correspondent Contact |
RAINER BIRKENBACH |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 10/25/2007 |
Decision Date | 01/23/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|