The following data is part of a premarket notification filed by Medxpress.pro with the FDA for Ez-cover.
Device ID | K191491 |
510k Number | K191491 |
Device Name: | EZ-Cover |
Classification | Transducer, Ultrasonic, Diagnostic |
Applicant | MedXPress.Pro Slachthuislaan 1, Bus 102 Leuven, BE 3000 |
Contact | Katherine Hughey |
Correspondent | Jeff Kasoff Lean To Quality, LLC 107 Avenue A Willis, TX 77378 |
Product Code | ITX |
CFR Regulation Number | 892.1570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-06-05 |
Decision Date | 2020-06-05 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05407006211181 | K191491 | 000 |
05407006210764 | K191491 | 000 |
05407006210795 | K191491 | 000 |
05407006210825 | K191491 | 000 |
05407006210856 | K191491 | 000 |
05407006210887 | K191491 | 000 |
05407006210917 | K191491 | 000 |
05407006210948 | K191491 | 000 |
05407006210979 | K191491 | 000 |
05407006211006 | K191491 | 000 |
05407006211037 | K191491 | 000 |
05407006211068 | K191491 | 000 |
05407006211099 | K191491 | 000 |
05407006211129 | K191491 | 000 |
05407006211150 | K191491 | 000 |
05407006210733 | K191491 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
EZ-COVER 98010519 not registered Live/Pending |
Ningbo Weiang Information Technology Co., Ltd. 2023-05-24 |
EZ-COVER 76433869 2713418 Live/Registered |
GERBER CHILDRENSWEAR LLC 2002-07-24 |
EZ-COVER 76028656 not registered Dead/Abandoned |
EZ-COVER Inc. 2000-04-18 |