Device Classification Name |
System, Monitoring, Perinatal
|
510(k) Number |
K904358 |
Device Name |
MODEL 855 ENHANCED PERFORMANCE REMOTE TERMINAL |
Applicant |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
61 BARNES PARK RD., NORTH |
WALLINGFORD,
CT
06492
|
|
Applicant Contact |
BRIAN BARRY |
Correspondent |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
61 BARNES PARK RD., NORTH |
WALLINGFORD,
CT
06492
|
|
Correspondent Contact |
BRIAN BARRY |
Regulation Number | 884.2740
|
Classification Product Code |
|
Date Received | 09/24/1990 |
Decision Date | 10/05/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|