The following data is part of a premarket notification filed by Xoran Technologies, Inc. with the FDA for Xoranconnect.
Device ID | K073306 |
510k Number | K073306 |
Device Name: | XORANCONNECT |
Classification | System, Image Processing, Radiological |
Applicant | XORAN TECHNOLOGIES, INC. 309 N. FIRST STREET Ann Arbor, MI 48103 -3301 |
Contact | Amy S Kim |
Correspondent | Amy S Kim XORAN TECHNOLOGIES, INC. 309 N. FIRST STREET Ann Arbor, MI 48103 -3301 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-11-23 |
Decision Date | 2008-01-07 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00860290000322 | K073306 | 000 |
00860290000384 | K073306 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
XORANCONNECT 77097428 3473031 Live/Registered |
XORAN TECHNOLOGIES LLC 2007-02-01 |