Device Classification Name |
System, Monitoring, Perinatal
|
510(k) Number |
K821580 |
Device Name |
FETAL MONITOR #FM 750 |
Applicant |
ADVANTAGE MEDICAL SYSTEMS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
ADVANTAGE MEDICAL SYSTEMS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 884.2740
|
Classification Product Code |
|
Date Received | 05/25/1982 |
Decision Date | 06/25/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|