Device Classification Name |
System, Monitoring, Perinatal
|
510(k) Number |
K880419 |
Device Name |
MODEL 800 O.B. DATA ARCHIVAL SYSTEM |
Applicant |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
61 BARNES PARK RD., NORTH |
WALLINGFORD,
CT
06492
|
|
Applicant Contact |
JOSEPH P LENZEN |
Correspondent |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
61 BARNES PARK RD., NORTH |
WALLINGFORD,
CT
06492
|
|
Correspondent Contact |
JOSEPH P LENZEN |
Regulation Number | 884.2740
|
Classification Product Code |
|
Date Received | 02/01/1988 |
Decision Date | 06/10/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|