The following data is part of a premarket notification filed by Adani with the FDA for Uniexpert 2 Plus.
Device ID | K200944 |
510k Number | K200944 |
Device Name: | UNIEXPERT 2 PLUS |
Classification | System, X-ray, Stationary |
Applicant | Adani 7 Selitsky Str. Minsk, BY 220075 |
Contact | Vladimir Linev |
Correspondent | Vladimir Linev Adani 7 Selitsky Str. Minsk, BY 220075 |
Product Code | KPR |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-04-08 |
Decision Date | 2020-05-26 |
Summary: | summary |