| Device Classification Name |
System, X-Ray, Mobile
|
| 510(k) Number |
K930699 |
| Device Name |
M6-M |
| Applicant |
| X-Cel X-Ray Corp. |
| 4220 Waller Dr., P.O. Box 1857 |
|
Crystal Lake,
IL
60039
|
|
| Applicant Contact |
WILLIAM MORRIS |
| Correspondent |
| X-Cel X-Ray Corp. |
| 4220 Waller Dr., P.O. Box 1857 |
|
Crystal Lake,
IL
60039
|
|
| Correspondent Contact |
WILLIAM MORRIS |
| Regulation Number | 892.1720 |
| Classification Product Code |
|
| Date Received | 02/10/1993 |
| Decision Date | 08/09/1993 |
| 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
|
|
|