Device Classification Name |
Transducer, Ultrasonic, Obstetric
|
510(k) Number |
K881263 |
Device Name |
MODEL 500A VASCULAR SPECTRUM ANALYZER W/DOPPLER |
Applicant |
MULTIGON INDUSTRIES, INC. |
P.O. BOX 2485 |
MT. VERNON,
NY
10551
|
|
Applicant Contact |
WILLIAM STERN |
Correspondent |
MULTIGON INDUSTRIES, INC. |
P.O. BOX 2485 |
MT. VERNON,
NY
10551
|
|
Correspondent Contact |
WILLIAM STERN |
Regulation Number | 884.2960
|
Classification Product Code |
|
Date Received | 03/24/1988 |
Decision Date | 01/05/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|