The following data is part of a premarket notification filed by General Electric Co. with the FDA for Advantage Sim.
Device ID | K951830 |
510k Number | K951830 |
Device Name: | ADVANTAGE SIM |
Classification | System, Simulation, Radiation Therapy |
Applicant | GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
Contact | Larry A Kroger |
Correspondent | Larry A Kroger GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
Product Code | KPQ |
CFR Regulation Number | 892.5840 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-04-20 |
Decision Date | 1995-11-13 |