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U.S. Department of Health and Human Services

510(k) Premarket Notification

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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 Number872.1800
Classification Product Code
MUH  
Date Received06/02/2021
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
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