The following data is part of a premarket notification filed by Voxel with the FDA for Voxgram.
Device ID | K954200 |
510k Number | K954200 |
Device Name: | VOXGRAM |
Classification | Film, Radiographic |
Applicant | VOXEL 26081 MERIT CIRCLE, #117 Laguna Hills, CA 92653 |
Contact | Murray Rudin |
Correspondent | Murray Rudin VOXEL 26081 MERIT CIRCLE, #117 Laguna Hills, CA 92653 |
Product Code | IWZ |
CFR Regulation Number | 892.1840 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-09-06 |
Decision Date | 1995-09-29 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
VOXGRAM 73768925 1574510 Dead/Cancelled |
VOXEL 1988-12-12 |