Device Classification Name |
imager, ultrasonic obstetric-gynecologic
|
510(k) Number |
K811520 |
Device Name |
GRAYLINE IMAGING SYSTEM |
Applicant |
SONICS RESEARCH CORP. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
SONICS RESEARCH CORP. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 884.2225
|
Classification Product Code |
|
Date Received | 05/29/1981 |
Decision Date | 07/02/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|