The following data is part of a premarket notification filed by General Electric Co. with the FDA for Ct 9000.
| Device ID | K843927 |
| 510k Number | K843927 |
| Device Name: | CT 9000 |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
| Contact | Howard Ii |
| Correspondent | Howard Ii GENERAL ELECTRIC CO. P.O. 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 | 1984-10-05 |
| Decision Date | 1984-12-17 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CT 9000 75098025 2069299 Live/Registered |
LIEBEL-FLARSHEIM COMPANY 1996-05-02 |