The following data is part of a premarket notification filed by Communications & Power Industries Canada, Inc. with the FDA for Cpi Rad Vision.
Device ID | K122726 |
510k Number | K122726 |
Device Name: | CPI RAD VISION |
Classification | System, X-ray, Stationary |
Applicant | COMMUNICATIONS & POWER INDUSTRIES CANADA, INC. 45 RIVER DRIVE Georgetown,ontario, CA L7g 2j4 |
Contact | Norm Morikawa |
Correspondent | Norm Morikawa COMMUNICATIONS & POWER INDUSTRIES CANADA, INC. 45 RIVER DRIVE Georgetown,ontario, CA L7g 2j4 |
Product Code | KPR |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-09-05 |
Decision Date | 2013-02-15 |
Summary: | summary |