Device Classification Name |
system, imaging, pulsed echo, ultrasonic
|
510(k) Number |
K990226 |
Device Name |
GE LOGIQ700 DIAGNOSTIC ULTRASOUND SYSTEM WITH B-FLOW |
Applicant |
GE MEDICAL SYSTEMS, INC. |
P.O. BOX 414 |
MILWAUKEE,
WI
53201
|
|
Applicant Contact |
ALLEN SCHUH |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
333 PFINGSTEN RD. |
NORTHBROOK,
IL
60062
|
|
Correspondent Contact |
CHANTEL CARSON |
Regulation Number | 892.1560
|
Classification Product Code |
|
Date Received | 01/25/1999 |
Decision Date | 02/09/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|