| 510(k) Number |
K827345 |
| Device Name |
VHR VIDEO SYSTEM |
| Applicant |
| General Electric Co. |
| 1 River Rd. |
|
Schenectady,
NY
12345
|
|
| Correspondent |
| General Electric Co. |
| 1 River Rd. |
|
Schenectady,
NY
12345
|
|
| Date Received | 04/15/1982 |
| Decision Date | 04/28/1982 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|