| Device Classification Name |
Transducer, Ultrasonic
|
| 510(k) Number |
K842539 |
| Device Name |
DIAGNOSTIC ULTRASOUND 105 & 110 |
| Applicant |
| Diagnostic Ultrasound Corp. |
| P.O. Box 0789 |
|
Kirkland,
WA
98083
|
|
| Applicant Contact |
GERALD MCMORROW |
| Correspondent |
| Diagnostic Ultrasound Corp. |
| P.O. Box 0789 |
|
Kirkland,
WA
98083
|
|
| Correspondent Contact |
GERALD MCMORROW |
| Regulation Number | 870.2880 |
| Classification Product Code |
|
| Date Received | 06/28/1984 |
| Decision Date | 04/10/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Cardiovascular
|
| 510k Review Panel |
Cardiovascular
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|