Device Classification Name |
Interventional Fluoroscopic X-Ray System
|
510(k) Number |
K170752 |
Device Name |
OEC Elite |
Applicant |
OEC Medical Systems, Inc. |
384 Wright Brothers Drive |
Salt Lake City,
UT
84116
|
|
Applicant Contact |
Helen Peng |
Correspondent |
OEC Medical Systems, Inc. |
384 Wright Brothers Drive |
Salt Lake City,
UT
84116
|
|
Correspondent Contact |
Helen Peng |
Regulation Number | 892.1650
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/13/2017 |
Decision Date | 05/19/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|