The following data is part of a premarket notification filed by Nucletron Corporation with the FDA for Spot Pro (220v), Model 131.099.
Device ID | K022741 |
510k Number | K022741 |
Device Name: | SPOT PRO (220V), MODEL 131.099 |
Classification | System, Planning, Radiation Therapy Treatment |
Applicant | NUCLETRON CORPORATION 7080 COLUMBIA GATEWAY DR. Columbia, MD 21046 -2133 |
Contact | Lisa Dimmick |
Correspondent | Lisa Dimmick NUCLETRON CORPORATION 7080 COLUMBIA GATEWAY DR. Columbia, MD 21046 -2133 |
Product Code | MUJ |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-08-19 |
Decision Date | 2002-10-24 |
Summary: | summary |