| 510(k) Number |
K837224 |
| Device Name |
UNKNOWN |
| Applicant |
| Xanar, Inc. |
| 2868 Janitell Rd. |
|
Colorado Springs,
CO
80906
|
|
| Correspondent |
| Xanar, Inc. |
| 2868 Janitell Rd. |
|
Colorado Springs,
CO
80906
|
|
| Date Received | 03/02/1983 |
| Decision Date | 05/02/1983 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|