| Device Classification Name |
System, Imaging, Pulsed Echo, Ultrasonic
|
| 510(k) Number |
K872726 |
| Device Name |
DGH-3000A A-SCAN |
| Applicant |
| Dgh Technology, Inc. |
| 446 Lancaster Ave. |
|
Frazer,
PA
19355
|
|
| Applicant Contact |
EARL W HENDERSON |
| Correspondent |
| Dgh Technology, Inc. |
| 446 Lancaster Ave. |
|
Frazer,
PA
19355
|
|
| Correspondent Contact |
EARL W HENDERSON |
| Regulation Number | 892.1560 |
| Classification Product Code |
|
| Date Received | 07/08/1987 |
| Decision Date | 12/04/1987 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Radiology
|
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|