Device Classification Name |
monitor, ultrasonic, fetal
|
510(k) Number |
K910153 |
Device Name |
UST-974-5 CONVEX TRANSDUCER |
Applicant |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
61 BARNES PARK RD., NORTH |
WALLINGFORD,
CT
06492
|
|
Applicant Contact |
BRIAN R BARRY |
Correspondent |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
61 BARNES PARK RD., NORTH |
WALLINGFORD,
CT
06492
|
|
Correspondent Contact |
BRIAN R BARRY |
Regulation Number | 884.2660
|
Classification Product Code |
|
Date Received | 01/14/1991 |
Decision Date | 03/29/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|