The following data is part of a premarket notification filed by Medicalip Co., Ltd with the FDA for Medip Pro.
Device ID | K191026 |
510k Number | K191026 |
Device Name: | MEDIP PRO |
Classification | System, Image Processing, Radiological |
Applicant | MEDICALIP Co., Ltd 7F Changkyung Building, 174, Yulgok-ro Jongno-gu, KR 03127 |
Contact | Yoon Bo Chung |
Correspondent | Geumhyeon Kim DT&S Co., Ltd. #202, Mario Tower, 28, Digital-ro 30-gil Guro-gu, KR 08389 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-04-18 |
Decision Date | 2019-11-07 |