Device Classification Name |
system, monitoring, perinatal
|
510(k) Number |
K841477 |
Device Name |
COROMETRICS 815 FETAL ECG RECORDER |
Applicant |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 884.2740
|
Classification Product Code |
|
Date Received | 04/09/1984 |
Decision Date | 05/14/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|