| 510(k) Number |
K827573 |
| Device Name |
DIASONICS CARDIO/IMAGING ECHOSCOPE |
| Applicant |
| Diasonics, Inc. |
| 1708 Mc Carthy Blvd. |
|
Milpitas,
CA
95035
|
|
| Correspondent |
| Diasonics, Inc. |
| 1708 Mc Carthy Blvd. |
|
Milpitas,
CA
95035
|
|
| Date Received | 07/23/1982 |
| Decision Date | 08/16/1982 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|