The following data is part of a premarket notification filed by General Electric Co. with the FDA for Advantage Windows 3d With Navigator Option.
Device ID | K954355 |
510k Number | K954355 |
Device Name: | ADVANTAGE WINDOWS 3D WITH NAVIGATOR OPTION |
Classification | System, Nuclear Magnetic Resonance Imaging |
Applicant | GENERAL ELECTRIC CO. P0 BOX 414 Milwaukee, WI |
Contact | Larry A Kroger |
Correspondent | Larry A Kroger GENERAL ELECTRIC CO. P0 BOX 414 Milwaukee, WI |
Product Code | LNH |
CFR Regulation Number | 892.1000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-09-18 |
Decision Date | 1995-11-14 |