Device Classification Name |
system, tomography, computed, emission
|
510(k) Number |
K201807 |
Device Name |
ANCORIS |
Applicant |
MiEGmbH |
Hauptstrasse 112 |
Seth,
DE
23845
|
|
Applicant Contact |
Thomas Kuehl |
Correspondent |
MiEGmbH |
Hauptstrasse 112 |
Seth,
DE
23845
|
|
Correspondent Contact |
Thomas Kuehl |
Regulation Number | 892.1200
|
Classification Product Code |
|
Date Received | 07/01/2020 |
Decision Date | 08/27/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|