The following data is part of a premarket notification filed by Lexi Co., Ltd. with the FDA for Zedview.
Device ID | K133022 |
510k Number | K133022 |
Device Name: | ZEDVIEW |
Classification | System, Image Processing, Radiological |
Applicant | LEXI CO., LTD. 5905 FAWN LANE Cleveland, OH 44141 |
Contact | Edward A Kroll |
Correspondent | Edward A Kroll LEXI CO., LTD. 5905 FAWN LANE Cleveland, OH 44141 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-09-26 |
Decision Date | 2014-03-06 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ZEDVIEW 87736895 not registered Live/Pending |
LEXI Co., Ltd. 2017-12-28 |