Device Classification Name |
Imager, Ultrasonic Obstetric-Gynecologic
|
510(k) Number |
K853711 |
Device Name |
5.0 MHZ INTRACAVITARY SECTOR PROBE |
Applicant |
GENERAL ELECTRIC CO. |
P.O. BOX 414 |
MILWAUKEE,
WI
53201
|
|
Applicant Contact |
JAMES M HOWARD |
Correspondent |
GENERAL ELECTRIC CO. |
P.O. BOX 414 |
MILWAUKEE,
WI
53201
|
|
Correspondent Contact |
JAMES M HOWARD |
Regulation Number | 884.2225
|
Classification Product Code |
|
Date Received | 09/05/1985 |
Decision Date | 12/18/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|