The following data is part of a premarket notification filed by Wide Corporation with the FDA for Mx30n(mx30tqs).
| Device ID | K160346 |
| 510k Number | K160346 |
| Device Name: | MX30N(MX30TQS) |
| 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 |
|---|---|---|
| 08809241513025 | K160346 | 000 |