Device Classification Name |
accelerator, linear, medical
|
510(k) Number |
K042794 |
Device Name |
BEAM MODULATOR, MODEL 4513 332 8000 |
Applicant |
ELEKTA LTD. |
4775 PEACHTREE INDUSTRIAL BLVD |
BLDG. 300, SUITE 300 |
NORCROSS,
GA
30092
|
|
Applicant Contact |
PETER STEGAGNO |
Correspondent |
ELEKTA LTD. |
4775 PEACHTREE INDUSTRIAL BLVD |
BLDG. 300, SUITE 300 |
NORCROSS,
GA
30092
|
|
Correspondent Contact |
PETER STEGAGNO |
Regulation Number | 892.5050
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/07/2004 |
Decision Date | 01/31/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|