The following data is part of a premarket notification filed by Wide Corporation with the FDA for Cx30n (cx30pqx).
| Device ID | K160348 |
| 510k Number | K160348 |
| Device Name: | CX30N (CX30PQX) |
| Classification | Display, Diagnostic Radiology |
| Applicant | WIDE CORPORATION 12 WONGOMAE-RO, GIHEUNG-GU Yongin-si, KR 17086 |
| Contact | Yeojin Yun |
| Correspondent | Yeojin Yun WIDE CORPORATION 12 WONGOMAE-RO, GIHEUNG-GU Yongin-si, KR 17086 |
| Product Code | PGY |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-08 |
| Decision Date | 2016-04-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809241513049 | K160348 | 000 |