| Device Classification Name |
System, Tomography, Computed, Emission
|
| 510(k) Number |
K992560 |
| Device Name |
MAPS 10000 |
| Applicant |
| Web Link Medical |
| 11800 Baltimore Ave. |
| Suite 105 |
|
Beltsville,
MD
20850
|
|
| Applicant Contact |
MELISSA MAHALL |
| Correspondent |
| Web Link Medical |
| 11800 Baltimore Ave. |
| Suite 105 |
|
Beltsville,
MD
20850
|
|
| Correspondent Contact |
MELISSA MAHALL |
| Regulation Number | 892.1200 |
| Classification Product Code |
|
| Date Received | 08/02/1999 |
| Decision Date | 10/29/1999 |
| 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
|
|
|