The following data is part of a premarket notification filed by X-ray Systems with the FDA for Upright Bucky Stand/mount.
Device ID | K855161 |
510k Number | K855161 |
Device Name: | UPRIGHT BUCKY STAND/MOUNT |
Classification | System, X-ray, Stationary |
Applicant | X-RAY SYSTEMS 33061 GROESBECK HWY. Fraser, MI 48026 -1514 |
Contact | Richard Drumb |
Correspondent | Richard Drumb X-RAY SYSTEMS 33061 GROESBECK HWY. Fraser, MI 48026 -1514 |
Product Code | KPR |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-12-26 |
Decision Date | 1986-02-12 |