| Device Classification Name |
System, Image Processing, Radiological
|
| 510(k) Number |
K990052 |
| Device Name |
TEL-ECHO SYSTEM |
| Applicant |
| Innovative Medical Solutions, Inc. |
| 1250 Newport Dr. |
|
Oconomowoc,
WI
53066
|
|
| Applicant Contact |
LAWRENCE E SIEB,JR |
| Correspondent |
| Innovative Medical Solutions, Inc. |
| 1250 Newport Dr. |
|
Oconomowoc,
WI
53066
|
|
| Correspondent Contact |
LAWRENCE E SIEB,JR |
| Regulation Number | 892.2050 |
| Classification Product Code |
|
| Date Received | 01/07/1999 |
| Decision Date | 02/19/1999 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Radiology
|
| 510k Review Panel |
Radiology
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|