| 510(k) Number |
K837605 |
| Device Name |
MV/CM2 NUMBER X74294 MODEL NUMBER 74229 |
| Applicant |
| Bio-Tek Instruments, Inc. |
| Highland Park |
| P.O. Box 998 |
|
Winooski,
VT
05404
|
|
| Correspondent |
| Bio-Tek Instruments, Inc. |
| Highland Park |
| P.O. Box 998 |
|
Winooski,
VT
05404
|
|
| Date Received | 05/16/1983 |
| Decision Date | 06/28/1983 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|