Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K002597 |
Device Name |
CN ACQUISITION STATION |
Applicant |
CARDIONOW, INC. |
535 ENCINITAS BLVD., SUITE 118 |
ENCINITAS,
CA
92024
|
|
Applicant Contact |
JOHNNY M GARZA |
Correspondent |
CARDIONOW, INC. |
535 ENCINITAS BLVD., SUITE 118 |
ENCINITAS,
CA
92024
|
|
Correspondent Contact |
JOHNNY M GARZA |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 08/21/2000 |
Decision Date | 11/17/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|