The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Advantage Windows 3d Option And Dentascan Option.
Device ID | K923077 |
510k Number | K923077 |
Device Name: | ADVANTAGE WINDOWS 3D OPTION AND DENTASCAN OPTION |
Classification | System, X-ray, Tomography, Computed |
Applicant | GE MEDICAL SYSTEMS PO BOX 414 Milwaukee, WI 53201 |
Contact | Larry A Kroger |
Correspondent | Larry A Kroger GE MEDICAL SYSTEMS PO BOX 414 Milwaukee, WI 53201 |
Product Code | JAK |
CFR Regulation Number | 892.1750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-06-25 |
Decision Date | 1993-02-02 |