| 510(k) Number |
K837033 |
| Device Name |
ROTATABLE HALF BEAM SHIELDING BLOCK MODEL 440 |
| Applicant |
| Radiation Measurements, Inc. |
| 7617 Donna Dr. |
|
Middleton,
WI
53562
|
|
| Correspondent |
| Radiation Measurements, Inc. |
| 7617 Donna Dr. |
|
Middleton,
WI
53562
|
|
| Date Received | 12/14/1982 |
| Decision Date | 03/09/1983 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|