| Device Classification Name |
System, Digital Image Communications, Radiological
|
| 510(k) Number |
K921185 |
| Device Name |
TELEMEDIC TELERADIOLOGY SYSTEM |
| Applicant |
| Meditron Corp. |
| P.O. Box 6419 |
|
Stateline,
NV
89449
|
|
| Applicant Contact |
DANIEL P AEBERLL |
| Correspondent |
| Meditron Corp. |
| P.O. Box 6419 |
|
Stateline,
NV
89449
|
|
| Correspondent Contact |
DANIEL P AEBERLL |
| Regulation Number | 892.2020 |
| Classification Product Code |
|
| Date Received | 03/09/1992 |
| Decision Date | 03/29/1993 |
| 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
|
|
|