| 510(k) Number |
K828051 |
| Device Name |
ADR ULTRASOUND MODEL 4000 SC OR 4000 S/LC |
| Applicant |
| Adr Ultrasound |
| 734 W. Alameda Dr. |
|
Tempe,
AZ
85282
|
|
| Correspondent |
| Adr Ultrasound |
| 734 W. Alameda Dr. |
|
Tempe,
AZ
85282
|
|
| Date Received | 08/31/1982 |
| Decision Date | 09/29/1982 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|