Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K200572 |
Device Name |
Planmeca Romexis |
Applicant |
Planmeca Oy |
Asentajankatu 6 |
Helsinki,
FI
00880
|
|
Applicant Contact |
Lars Moring |
Correspondent |
Planmeca Oy |
Asentajankatu 6 |
Helsinki,
FI
00880
|
|
Correspondent Contact |
Lars Moring |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 03/05/2020 |
Decision Date | 12/02/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|