Device Classification Name |
Monitor, Ultrasonic, Fetal
|
510(k) Number |
K802024 |
Device Name |
GRAVIDAPHONE |
Applicant |
SOLAR ELECTRONICS |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
SOLAR ELECTRONICS |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 884.2660
|
Classification Product Code |
|
Date Received | 08/20/1980 |
Decision Date | 01/07/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|