Device Classification Name |
transducer, ultrasonic, obstetric
|
510(k) Number |
K875334 |
Device Name |
KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM |
Applicant |
KONTRON INSTRUMENTS, INC. |
9 PLYMOUTH ST. |
EVERETT,
MA
02149
|
|
Applicant Contact |
DAVID CROMWICK |
Correspondent |
KONTRON INSTRUMENTS, INC. |
9 PLYMOUTH ST. |
EVERETT,
MA
02149
|
|
Correspondent Contact |
DAVID CROMWICK |
Regulation Number | 884.2960
|
Classification Product Code |
|
Date Received | 12/30/1987 |
Decision Date | 03/24/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|