| Device Classification Name |
System,X-Ray,Extraoral Source,Digital
More FDA Info for this Device |
| 510(K) Number |
K220277 |
| Device Name |
System,X-Ray,Extraoral Source,Digital |
| Applicant |
Shenzhen Xpectvision Technology Co.,Ltd.
B507,Block A and B,Nanshan Medical Device Industrial Park,
Nanhai Avenue 1019,Nanshan District
Shenzhen 518067 CN
Other 510(k) Applications for this Company
|
| Contact |
Mengsi Peng
Other 510(k) Applications for this Contact |
| Regulation Number |
872.1800
More FDA Info for this Regulation Number |
| Classification Product Code |
MUH
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
| Date Received |
01/31/2022 |
| Decision Date |
02/17/2022 |
| 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 |
|