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 |