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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, X-Ray, Extraoral With Timer
510(k) Number K220579
Device Name Hybrid C70
Applicant
Digimed Co., Ltd.
309-311, 318-Ho
145, Gasan Digital 1-Ro, Geumcheon-Gu
Seul,  KR 08506
Applicant Contact Youngbae Kwon
Correspondent
Digimed Co., Ltd.
309-311, 318-Ho
145, Gasan Digital 1-Ro, Geumcheon-Gu
Seul,  KR 08506
Correspondent Contact Youngbae Kwon
Regulation Number872.1800
Classification Product Code
EHD  
Date Received02/21/2022
Decision Date 09/01/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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