Device Classification Name |
system, x-ray, extraoral source, digital
|
510(k) Number |
K211688 |
Device Name |
DC-Air and Athlos-1 and Athlos-Air |
Applicant |
Athlos Oy |
Klovinpellontie 1-3, Tower 2 |
Espoo,
FI
02180
|
|
Applicant Contact |
Konstantinos Spartiotis |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
Prithul Bom |
Regulation Number | 872.1800
|
Classification Product Code |
|
Date Received | 06/02/2021 |
Decision Date | 07/22/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|