The following data is part of a premarket notification filed by General Electric Medical Systems with the FDA for Advantage Sim 6.0.
Device ID | K021780 |
510k Number | K021780 |
Device Name: | ADVANTAGE SIM 6.0 |
Classification | System, Simulation, Radiation Therapy |
Applicant | GENERAL ELECTRIC MEDICAL SYSTEMS 3000 NORTH GRANDVIEW BLVD. Waukesha, WI 53188 |
Contact | Larry A Kroger |
Correspondent | Wolfram Gmelin TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
Product Code | KPQ |
CFR Regulation Number | 892.5840 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2002-05-30 |
Decision Date | 2002-07-29 |
Summary: | summary |