| 510(k) Number |
K827064 |
| Device Name |
SIEMENS POLYDOROS 800 |
| Applicant |
| Siemens Medical Solutions USA, Inc. |
| 22010 SE 51st St. |
|
Issaquah,
WA
98027
|
|
| Correspondent |
| Siemens Medical Solutions USA, Inc. |
| 22010 SE 51st St. |
|
Issaquah,
WA
98027
|
|
| Date Received | 01/15/1982 |
| Decision Date | 02/24/1982 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|