| Device Classification Name |
System, Imaging, Pulsed Echo, Ultrasonic
|
| 510(k) Number |
K853147 |
| Device Name |
SCANO 731B & 731C ULTRASOUND SOFT TIS DEPT MEAS SY |
| Applicant |
| Scano, Inc. |
| 2776 N. Triphammer Rd., Rd. 1 |
|
Ithaca,
NY
14850
|
|
| Applicant Contact |
WENDELL HAUTANIEM |
| Correspondent |
| Scano, Inc. |
| 2776 N. Triphammer Rd., Rd. 1 |
|
Ithaca,
NY
14850
|
|
| Correspondent Contact |
WENDELL HAUTANIEM |
| Regulation Number | 892.1560 |
| Classification Product Code |
|
| Date Received | 07/29/1985 |
| Decision Date | 03/13/1986 |
| 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
|
|
|