Device Classification Name |
X-Ray, Tomography, Computed, Dental
|
510(k) Number |
K213278 |
Device Name |
Planmed Verity |
Applicant |
Planmed Oy |
Sorvaajankatu 7 |
Helsinki,
FI
00880
|
|
Applicant Contact |
Niina Vuorikallas |
Correspondent |
Planmed Oy |
Sorvaajankatu 7 |
Helsinki,
FI
00880
|
|
Correspondent Contact |
Niina Vuorikallas |
Regulation Number | 892.1750
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/01/2021 |
Decision Date | 04/28/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|