| 510(k) Number |
K827069 |
| Device Name |
PODIOSCOPE BY ARROW |
| Applicant |
| Arrow X-Ray Corp. |
| 7129 39th Ave. SW |
|
Seattle,
WA
98136
|
|
| Correspondent |
| Arrow X-Ray Corp. |
| 7129 39th Ave. SW |
|
Seattle,
WA
98136
|
|
| Date Received | 01/18/1982 |
| Decision Date | 02/18/1982 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|