| 510(k) Number |
K837171 |
| Device Name |
ULTRASONIC ECHOSCOPE |
| Applicant |
| Ausonics Pty , Ltd. |
| 16 Mars Rd. |
| Ln. Cove, N.Sw |
|
Austrailia,
2006
|
|
| Correspondent |
| Ausonics Pty , Ltd. |
| 16 Mars Rd. |
| Ln. Cove, N.Sw |
|
Austrailia,
2006
|
|
| Date Received | 02/16/1983 |
| Decision Date | 03/17/1983 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|