Device Classification Name |
System, X-Ray, Fluoroscopic, Image-Intensified
|
510(k) Number |
K843920 |
Device Name |
FLUOROSCAN/TM BY HEALTHMATE |
Applicant |
HEALTHMATE, INC. |
3000 DUNDEE ROAD |
NORTHBROOK ,
IL
60062 -
|
|
Applicant Contact |
KEN WIESELMAN |
Correspondent |
HEALTHMATE, INC. |
3000 DUNDEE ROAD |
NORTHBROOK ,
IL
60062 -
|
|
Correspondent Contact |
KEN WIESELMAN |
Regulation Number | 892.1650
|
Classification Product Code |
|
Date Received | 10/05/1984 |
Decision Date | 02/07/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|