The following data is part of a premarket notification filed by Lg Electronics.inc with the FDA for X-clever.
Device ID | K212137 |
510k Number | K212137 |
Device Name: | X-Clever |
Classification | System, Image Processing, Radiological |
Applicant | LG Electronics.Inc 77, Sanho-Daero, Gyeongbuk Gumi-si, KR 39381 |
Contact | Jin-hwan Jun |
Correspondent | Bokyeong Kim GMS Consulting 4th Floor, Digital Cube, 34, Sangamsan-ro Seoul, KR 03909 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-07-08 |
Decision Date | 2021-12-10 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00195174051306 | K212137 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
X-CLEVER 90794938 not registered Live/Pending |
LG ELECTRONICS INC. 2021-06-25 |