Device Classification Name |
x-ray, tomography, computed, dental
|
510(k) Number |
K201667 |
Device Name |
Midmark Extraoral Imaging System (EOIS) |
Applicant |
Midmark Corporation |
1001 Asbury Drive |
Buffalo Grove,
IL
60089
|
|
Applicant Contact |
Mark Kenar |
Correspondent |
Midmark Corporation |
1001 Asbury Drive |
Buffalo Grove,
IL
60089
|
|
Correspondent Contact |
Mark Kenar |
Regulation Number | 892.1750
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/19/2020 |
Decision Date | 08/06/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|