The following data is part of a premarket notification filed by Kub Technologies, Inc with the FDA for Digiview 250.
Device ID | K103348 |
510k Number | K103348 |
Device Name: | DIGIVIEW 250 |
Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
Applicant | KUB TECHNOLOGIES, INC 270 ROWE AVENUE SUITE E Milford, CT 06460 |
Contact | Vikram Butani |
Correspondent | Vikram Butani KUB TECHNOLOGIES, INC 270 ROWE AVENUE SUITE E Milford, CT 06460 |
Product Code | MQB |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-11-15 |
Decision Date | 2011-10-20 |
Summary: | summary |