The following data is part of a premarket notification filed by Wide Corporation with the FDA for Cx30n (cx30pqx).
| Device ID | K210493 |
| 510k Number | K210493 |
| Device Name: | CX30N (CX30PQX) |
| Classification | Display, Diagnostic Radiology |
| Applicant | Wide Corporation 15F, The First Tower III, 602, Dongtangiheung-Ro Hwaseong-si, KR 18469 |
| Contact | Yeojin Yun |
| Correspondent | Yeojin Yun Wide Corporation 15F, The First Tower III, 602, Dongtangiheung-Ro Hwaseong-si, KR 18469 |
| Product Code | PGY |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-19 |
| Decision Date | 2021-04-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809241513131 | K210493 | 000 |