| Device Classification Name |
Cabinet, X-Ray System
|
| 510(k) Number |
K071233 |
| Device Name |
XPERT 40 SPECIMEN RADIOGRAPHY SYSTEM |
| Applicant |
| KUB TECHNOLOGIES, INC |
| 543 LONG HILL AVENUE |
|
SHELTON,
CT
06824
|
|
| Applicant Contact |
JOSEPH M AZARY |
| Correspondent |
| KUB TECHNOLOGIES, INC |
| 543 LONG HILL AVENUE |
|
SHELTON,
CT
06824
|
|
| Correspondent Contact |
JOSEPH M AZARY |
| Regulation Number | 892.1680 |
| Classification Product Code |
|
| Date Received | 05/03/2007 |
| Decision Date | 06/20/2007 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Radiology
|
| 510k Review Panel |
Radiology
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|