| Device Classification Name |
Camera, Multi Format, Radiological
|
| 510(k) Number |
K843582 |
| Device Name |
MULTI-FORMAT FILM CAMERA |
| Applicant |
| Bfi- Medical Waste Systems |
| 1500 Hicks Rd. |
|
Rolling Meadows,
IL
60008
|
|
| Applicant Contact |
DAVID PEERENBOOM |
| Correspondent |
| Bfi- Medical Waste Systems |
| 1500 Hicks Rd. |
|
Rolling Meadows,
IL
60008
|
|
| Correspondent Contact |
DAVID PEERENBOOM |
| Regulation Number | 892.2040 |
| Classification Product Code |
|
| Date Received | 09/11/1984 |
| Decision Date | 10/25/1984 |
| 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
|
|
|