Device Classification Name |
Image-Intensified Fluoroscopic X-Ray System, Mobile
|
510(k) Number |
K935580 |
Device Name |
PHF20 20 MOBILE C-ARM IMAGE INTENSIFIER |
Applicant |
PRECISE OPTICS |
239 SOUTH FEHR WAY |
BAY SHORE,
NY
11706
|
|
Applicant Contact |
RON HANNINGTON |
Correspondent |
PRECISE OPTICS |
239 SOUTH FEHR WAY |
BAY SHORE,
NY
11706
|
|
Correspondent Contact |
RON HANNINGTON |
Regulation Number | 892.1650
|
Classification Product Code |
|
Date Received | 11/18/1993 |
Decision Date | 03/16/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|