Device Classification Name |
Unit, X-Ray, Extraoral With Timer
More FDA Info for this Device |
510(K) Number |
K221233 |
Device Name |
Unit, X-Ray, Extraoral With Timer |
Applicant |
ECOTRON Co., Ltd
404, 504, 505Ho, Hanshin IT Tower II, 47, Digital-ro 9-gil
Geumcheon-Gu,
Seoul 08511 KR
Other 510(k) Applications for this Company
|
Contact |
Sang Bong Lee
Other 510(k) Applications for this Contact |
Regulation Number |
872.1800
More FDA Info for this Regulation Number |
Classification Product Code |
EHD
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
04/29/2022 |
Decision Date |
06/27/2022 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
DE - Dental |
Review Advisory Committee |
RA - Radiology |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|