| 510(k) Number |
K827408 |
| Device Name |
ULTRA IMAGER |
| Applicant |
| Honeywell, Inc. |
| Honeywell Plz. |
|
Minneapolis,
MN
55408
|
|
| Correspondent |
| Honeywell, Inc. |
| Honeywell Plz. |
|
Minneapolis,
MN
55408
|
|
| Date Received | 07/28/1982 |
| Decision Date | 10/04/1982 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|