Device Classification Name |
Image-Intensified Fluoroscopic X-Ray System, Mobile
|
510(k) Number |
K911739 |
Device Name |
SWEMAC REISON BIPLANAR 300 |
Applicant |
SEEMAC REISON AB CO. |
INDUSTRIGATAN 11 |
S-582 31 LINKOPING, |
SWEDEN,
SE
|
|
Applicant Contact |
TORE NORMANN |
Correspondent |
SEEMAC REISON AB CO. |
INDUSTRIGATAN 11 |
S-582 31 LINKOPING, |
SWEDEN,
SE
|
|
Correspondent Contact |
TORE NORMANN |
Regulation Number | 892.1650
|
Classification Product Code |
|
Date Received | 04/17/1991 |
Decision Date | 10/23/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|