| Device Classification Name |
Generator, High-Voltage, X-Ray, Diagnostic
|
| 510(k) Number |
K910820 |
| Device Name |
VPW 2877E6 X-RAY POWER SUPPLY |
| Applicant |
| Varian Canada, Inc. |
| 45 River Dr. |
| Georgetown, Ontario |
|
Canada L7g 2j4,
CA
|
|
| Applicant Contact |
ANTHONY B BAILEY |
| Correspondent |
| Varian Canada, Inc. |
| 45 River Dr. |
| Georgetown, Ontario |
|
Canada L7g 2j4,
CA
|
|
| Correspondent Contact |
ANTHONY B BAILEY |
| Regulation Number | 892.1700 |
| Classification Product Code |
|
| Date Received | 02/25/1991 |
| Decision Date | 03/07/1991 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Radiology
|
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|