Device Classification Name |
Digitizer, Image, Radiological
|
510(k) Number |
K021949 |
Device Name |
FULCRUM |
Applicant |
HOWTEK, INC. |
21 PARK AVE. |
HUDSON,
NH
03051
|
|
Applicant Contact |
JOHN E ROSENSTENGEL |
Correspondent |
HOWTEK, INC. |
21 PARK AVE. |
HUDSON,
NH
03051
|
|
Correspondent Contact |
JOHN E ROSENSTENGEL |
Regulation Number | 892.2030
|
Classification Product Code |
|
Date Received | 06/13/2002 |
Decision Date | 08/12/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|