The following data is part of a premarket notification filed by Xoran Technologies, Inc. with the FDA for Xcat; Xcat For Neuro.
Device ID | K061834 |
510k Number | K061834 |
Device Name: | XCAT; XCAT FOR NEURO |
Classification | System, X-ray, Tomography, Computed |
Applicant | XORAN TECHNOLOGIES, INC. 309 N. FIRST STREET Ann Arbor, MI 48103 -3301 |
Contact | Jim Bertolina |
Correspondent | Jim Bertolina XORAN TECHNOLOGIES, INC. 309 N. FIRST STREET Ann Arbor, MI 48103 -3301 |
Product Code | JAK |
CFR Regulation Number | 892.1750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-06-29 |
Decision Date | 2006-08-07 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00860290000346 | K061834 | 000 |
00860290000339 | K061834 | 000 |
00860290000360 | K061834 | 000 |