The following data is part of a premarket notification filed by Ue Lifesciences Inc. with the FDA for Ibreastexam.
Device ID | K190575 |
510k Number | K190575 |
Device Name: | IBreastExam |
Classification | System, Documentation, Breast Lesion |
Applicant | UE LifeSciences Inc. 3401 Market St, Suite 200 Philadelphia, PA 19104 |
Contact | Mihir Shah |
Correspondent | Mihir Shah UE LifeSciences Inc. 3401 Market St, Suite 200 Philadelphia, PA 19104 |
Product Code | NKA |
CFR Regulation Number | 884.2990 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-03-06 |
Decision Date | 2019-07-16 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() IBREASTEXAM 97259724 not registered Live/Pending |
UE LIFESCIENCES INC. 2022-02-09 |