Device Classification Name |
Transducer, Ultrasonic, Diagnostic
|
510(k) Number |
K002193 |
Device Name |
TETRAD TC-C3-ACP |
Applicant |
TETRAD CORP. |
357 INVERNESS DR. SOUTH, |
SUITE A |
ENGLEWOOD,
CO
80112
|
|
Applicant Contact |
DENNIS R DIETZ |
Correspondent |
TETRAD CORP. |
357 INVERNESS DR. SOUTH, |
SUITE A |
ENGLEWOOD,
CO
80112
|
|
Correspondent Contact |
DENNIS R DIETZ |
Regulation Number | 892.1570
|
Classification Product Code |
|
Date Received | 07/20/2000 |
Decision Date | 05/04/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|