Device Classification Name |
System, Tomography, Computed, Emission
|
510(k) Number |
K982911 |
Device Name |
FORTE |
Applicant |
ADAC LABORATORIES |
540 ALDER DR. |
MILPITAS,
CA
95035
|
|
Applicant Contact |
DENNIS W HENKELMAN |
Correspondent |
ADAC LABORATORIES |
540 ALDER DR. |
MILPITAS,
CA
95035
|
|
Correspondent Contact |
DENNIS W HENKELMAN |
Regulation Number | 892.1200
|
Classification Product Code |
|
Date Received | 08/18/1998 |
Decision Date | 11/16/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|