Device Classification Name |
Unit, X-Ray, Extraoral With Timer
More FDA Info for this Device |
510(K) Number |
K201800 |
Device Name |
Unit, X-Ray, Extraoral With Timer |
Applicant |
NANORAY Co., Ltd.
#401, #402, #403, #408, #409, 76, Dongnae-ro, Dong-gu
Daegu 41061 KR
Other 510(k) Applications for this Company
|
Contact |
Won Hyun Sung
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 |
06/30/2020 |
Decision Date |
12/28/2020 |
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 |
|