Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K861279 |
Device Name |
FLUORO PLUS |
Applicant |
ADVANTAGE MEDICAL SYSTEMS, INC. |
306 MAIN ST. |
MILLBURN,
NJ
07041
|
|
Applicant Contact |
ROBERT FOLLMER |
Correspondent |
ADVANTAGE MEDICAL SYSTEMS, INC. |
306 MAIN ST. |
MILLBURN,
NJ
07041
|
|
Correspondent Contact |
ROBERT FOLLMER |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 04/07/1986 |
Decision Date | 06/16/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|