The following data is part of a premarket notification filed by Techheim Co., Ltd with the FDA for Nubex.
Device ID | K211480 |
510k Number | K211480 |
Device Name: | NubeX |
Classification | System, Image Processing, Radiological |
Applicant | TechHeim Co., Ltd Floor 3.4, 21, Banpo-daero 24-gil Seoul, KR 06648 |
Contact | Weon Yong Lee |
Correspondent | Jeongkeun Kim KMC, Inc. Room No. 1709, 123, Digital-ro 26-gil, Guro-gu Seoul, KR 08390 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-05-12 |
Decision Date | 2021-07-08 |