Device Classification Name |
Camera, Multi Format, Radiological
|
510(k) Number |
K021054 |
Device Name |
CODONICS HORIZON CI MEDICAL MULTIMEDIA DRY IMAGER; CODONICS HORIZON GS MEDICAL MULTIMEDIA GREY SCALE DRY IMAGER |
Applicant |
CODONICS, INC. |
17991 ENGLEWOOD DR. |
MIDDLEBURG HEIGHTS,
OH
44130
|
|
Applicant Contact |
RICK DAYTON |
Correspondent |
CODONICS, INC. |
17991 ENGLEWOOD DR. |
MIDDLEBURG HEIGHTS,
OH
44130
|
|
Correspondent Contact |
RICK DAYTON |
Regulation Number | 892.2040
|
Classification Product Code |
|
Date Received | 04/01/2002 |
Decision Date | 05/09/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|